Comparison of ondansetron and cyclizine for prevention of nausea and vomiting after day-case gynaecological laparoscopy

We have compared ondansetron 4 mg i.v. and cyclizine 50 mg i.v., in a double-blind, randomized, placebo-controlled study for the prevention of postoperative nausea and vomiting (PONV) for 24 h after day-case gynaecological laparoscopy. Compared with placebo (n = 58), ondansetron (n = 60) and cyclizine (n = 57) reduced significantly the incidence of moderate or severe nausea (30% and 23% vs 52%; P = 0.02 and P = 0.001, respectively) and requirement for escape antiemetic (28% and 16% vs 47%; P = 0.04 and P < 0.001, respectively) before discharge from hospital. There were no significant differences in PONV after discharge. Significantly more patients suffered no PONV before and after discharge after ondansetron and cyclizine compared with placebo (31% and 33% vs 12%; P = 0.02 and P < 0.01, respectively). For diagnostic laparoscopy (n = 74), fewer patients received escape antiemetic after cyclizine than after ondansetron (4% vs 37%; P < 0.01); for laparoscopic sterilization (n = 101), both antiemetics were equally effective. Ondansetron and cyclizine both reduced severe and moderate nausea and the need for antiemetic therapy after day-case gynaecological laparoscopy.      

Prophylaxis of postoperative nausea and vomiting with oral, long-acting dimenhydrinate in gynecologic outpatient laparoscopy

Dimenhydrinate is an inexpensive antiemetic with few side effects available as an oral, long-acting (LA) formulation (Gravol L/A) containing 25 mg of immediate and 50 mg of sustained release drug. We designed this double-blind comparison trial to assess the efficacy of dimenhydrinate LA versus droperidol alone and the combination for prophylaxis of nausea, vomiting, and retching in outpatient gynecologic laparoscopy. One-hundred-forty-one women were randomized into 3 groups: 1) droperidol (placebo capsule preoperatively and IV droperidol 0.625 mg before induction), 2) dimenhydrinate LA preoperatively and IV placebo before induction, or 3) combination. Information regarding nausea, vomiting, retching, pain, and sedation was recorded in the postanesthesia care unit (PACU) and collected by telephone for the presence of symptoms: on arrival home; at bedtime; upon arising, and at lunchtime the following day. The overall incidence of complete treatment failure (rescue medication in PACU or nausea, vomiting, or retching at any time point) was 28 of 46 (61%), 28 of 48 (58%), and 22 of 47 (47%); and for treatment failure vomiting (rescue medication in PACU or vomiting or retching at any time point) was 16 of 46 (35%), 11 of 48 (23%), and 5 of 47 (11%), for the droperidol, dimenhydrinate, and combination groups, respectively (P = 0.007 for droperidol versus combination). There were no differences in sedation or pain. Preoperative administration of an oral dose of LA dimenhydrinate in combination with droperidol when compared with droperidol alone effectively reduced the incidence of vomiting but not nausea in women undergoing elective outpatient gynecologic laparoscopy. IMPLICATIONS: Dimenhydrinate is an inexpensive antiemetic with few side effects available as a long-acting oral formulation. Women undergoing outpatient gynecologic laparoscopy were given droperidol, an effective antiemetic, dimenhydrinate alone, or the combination of the two drugs. Dimenhydrinate plus droperidol significantly reduced the overall incidence of vomiting, but not nausea, when compared with droperidol alone.     

Individualized outcome feedback produces voluntary antiemetic prescribing practice changes.

STUDY OBJECTIVE: To determine the impact of individualized outcome feedback on antiemetic prescribing practices and compare outcomes of a cost-effective, standardized antiemetic protocol (PROT) to that of customized antiemetic therapy (NONPROT). DESIGN: Prospective, observational study with randomized component. SETTING: Postanesthesia care unit (PACU) of an academic medical center. PATIENTS: 3027 consecutive ASA physical status I, II, and III patients receiving general anesthesia. INTERVENTIONS: Patients were randomized to receive 0.625 mg droperidol or 4 mg ondansetron for postoperative nausea and/or vomiting (PONV) from a protocol, or received customized antiemetic therapy. MEASUREMENTS AND MAIN RESULTS: Incidence of PACU PONV, selection of PROT versus NONPROT, patient satisfaction, and use of PONV prophylaxis were measured and indexed by an attending anesthesiologist in a monthly report for 4 months. Monthly expenditures for antiemetic therapy prior to, during, and after the study were collected. Literature on PONV outcomes, appropriate timing, and selection of PONV prophylaxis was distributed. The NONPROT group was slightly older than the PROT group; otherwise, demographics were similar between all groups. The incidence of PONV did not differ between the PROT and NONPROT groups (11% vs. 10%), and the incidence of PONV in patients receiving prophylaxis was higher in both groups (17% PROT vs. 15% NONPROT). Patients receiving ondansetron as a first-line drug required rescue therapy less often (5%) than those receiving droperidol (14%); however, patient satisfaction was indistinguishable among all groups. During the study, the use of prophylaxis decreased 47% without an increase in PONV, and PROT selection increased 54%. CONCLUSIONS: Individualized outcome feedback produced a 48% reduction in monthly expenditures for ondansetron and droperidol, which was sustained after the study. Patients satisfaction between ondansetron 4 mg and droperidol 0.625 mg given in the PACU did not differ in spite of a slightly greater efficacy of ondansetron as a first-line drug.     

Treating "rebound" emesis following outpatient gynecologic laparoscopy: the efficacy of a two-dose regimen of droperidol and ondansetron.

STUDY OBJECTIVE: To evaluate the efficacy of a two-dose combination of droperidol and ondansetron as compared with single-dose droperidol alone, single-dose combined droperidol and ondansetron, and two-dose droperidol alone, for management of postoperative nausea and vomiting (PONV) among gynecologic laparoscopy outpatients. DESIGN: Randomized, double-blind comparison trial. SETTING: Tertiary outpatient gynecologic unit. PATIENTS: A total of 120 female patients scheduled for gynecologic laparoscopy were enrolled. Patients who had experienced nausea or vomiting, or who had taken drugs with antiemetic action in the 24-hour period prior to the study, as well as breast-feeding mothers, were excluded from participation. INTERVENTIONS: Patients were assigned to four treatment groups: i) single dose of droperidol 1.25 mg, ii) two doses of droperidol 1.25 mg, iii) single dose of droperidol 1.25 mg and ondansetron 4 mg in combination, and iv) two doses of droperidol 1.25 mg and ondansetron 4 mg in combination. The first dose of antiemetic was administered prior to induction and the second dose was given by infusion 4 hours later, prior to discharge. MEASUREMENTS AND MAIN RESULTS: A visual analogue scale (VAS, 10 cm) was used to obtain patients' experience of nausea, vomiting, and pain at 0.5, 1.5, 2.5, and 3.5 hours after arrival at the postanesthetic care unit (PACU). Following discharge, approximately 24 hours after arrival at the PACU, the same measures were obtained by a follow-up interview using a verbal 10-point scale. No significant differences in incidence of PONV were noted among the four treatment groups (p = 0.419). However, both single- and two-dose droperidol and ondansetron combination therapy demonstrated attenuation of PONV severity in the 3.5- to 24-hour postinduction period (p < 0.05). CONCLUSIONS: The findings of this study suggest that prophylactic two-dose combined ondansetron and droperidol offers no added benefit over single-dose therapy for routine use in the gynecologic outpatient population.     

The effectiveness of rescue antiemetics after failure of prophylaxis with ondansetron or droperidol: a preliminary report

STUDY OBJECTIVES: To compare the effectiveness of treating established postoperative nausea and vomiting (PONV) with an antiemetic acting at a different receptor with that of treating PONV with the antiemetic used for prophylaxis. DESIGN: Analysis of data collected in a previously published randomized, double-blind, placebo-controlled study. SETTING: Outpatient surgical procedures from 50 institutions in North America. PATIENTS: Patients (N = 2061) undergoing outpatient surgical procedures planned to last no more than 2 hours. INTERVENTIONS: Patients were randomized to receive ondansetron 4 mg, droperidol 1.25, droperidol 0.625 mg, or placebo. In the postoperative anesthesia care unit, patients who developed PONV received rescue antiemetics at the discretion of the attending anesthesiologist. The following antiemetics were used for rescue: ondansetron 4 mg, droperidol 0.625 to 1.25 mg, metoclopramide 10 mg, promethazine 6.25 to 25 mg, and dimenhydrinate 25 to 50 mg. MEASUREMENTS: The complete response rate (no nausea, no emesis, and no need for further rescue) after administration of the rescue antiemetic in patients with established PONV was calculated. The complete response rate after administration of each of the different rescue antiemetics was compared with that after administration of the same antiemetic used for PONV prophylaxis. MAIN RESULTS: In patients who failed prophylaxis with ondansetron 4 mg, the complete response rate was significantly higher (P = .02) after rescue with promethazine 6.25 to 25 mg (78%) than after rescue with ondansetron 4 mg (46%). In patients who failed prophylaxis with droperidol 0.625 and 1.25 mg, the complete response rate was significantly higher after rescue with promethazine 6.25 to 25 mg (77%; P = .02) and dimenhydrinate 25 to 50 mg (78%; P = .04) than after rescue with droperidol 0.625 to 1.25 mg (56%). CONCLUSION: In patients who failed prophylaxis with ondansetron or droperidol, promethazine was significantly more effective than the agent used for prophylaxis for the treatment of PONV. In patients who failed prophylaxis with droperidol, dimenhydrinate was also more effective than droperidol for the treatment of established PONV in the postoperative anesthesia care unit.     

Patient-controlled antiemesis: a randomized, double-blind comparison of two doses of propofol versus placebo.

BACKGROUND: The role of propofol for the management of postoperative nausea and vomiting (PONV) is not well established. This study determines the efficacy of small doses of propofol administered by patient-controlled device for the treatment of PONV. METHODS: Patients presenting for ambulatory surgery received a standardized general anesthetic. Those who experienced significant nausea or emesis within 1 h of arrival in the recovery room were randomized to receive repeated doses of propofol 20 mg (P-20), propofol 40 mg (P-40), or intralipid (placebo) on demand. Study medications (in equal volumes) were administered with a patient-controlled delivery device for 2 h. A lockout interval of 5 min between doses was used. The following parameters were assessed: nausea, vomiting, rescue antiemetic use, recovery profile, study drug administration history, and satisfaction with treatment. RESULTS: Sixty-nine patients participated in the study. Patient demographics were similar. The average nausea score for a patient in the P-20 and P-40 groups was 25% and 29% less, respectively, compared with placebo during the study period (P < 0.05). This difference was apparent 15 min after initiation of therapy. More placebo patients vomited (P-20, 12%; P-40, 23%; placebo, 56%; P = 0.003) and needed rescue antiemetics (P-20, 17%; P-40, 23%; placebo, 70%; P = 0.001) compared with treatment groups. Sedation scores were similar between groups. Propofol-treated patients had shorter stays in the post-anesthesia care unit (PACU; P-20, 131+/-35 min [mean +/- SD]; P-40, 141+/-34 min; placebo, 191+/-92 min; P = 0.005) and higher satisfaction with their control of PONV than placebo (P < 0.01). CONCLUSIONS: Propofol is effective in managing PONV with shorter PACU stay and great degree of patient satisfaction. There were two episodes of oversedation in the P-40 group. Hence, propofol at a demand dose of 20 mg seems more appropriate.     

Ondansetron prevents postoperative emesis in male outpatients

Study Objectives: To determine (1) the efficacy and safety of ondansetron in the prevention of postoperative nausea and vomiting (PONV) in male outpatients; (2) prognostic factors for PONV in male outpatients; and (3) patients' perceptions of the debilitating effects of PONV in the ambulatory surgery setting.Design: Prospective, randomized, stratified, double-blind study.Setting: Multicenter—24 medical centers.Patients: 468 ASA physical status I and II males at least 12 years of age scheduled for general anesthesia.Interventions: All patients received intravenous ondansetron 4 mg or placebo prior to undergoing general balanced (opioid) anesthesia.Measurements and Main Results: In the postanesthesia care unit (PACU), the number of emetic episodes, vital signs, adverse events, and nausea assessments were recorded by a blinded observer. After discharge, and until the end of the 24-hour study period, patients completed a diary that collected emetic episodes, adverse events, nausea, and pharmacoeconomic data. There were no differences in patient demographics or safety profiles between groups. The number of patients with no emesis and no nausea during the 24-hour study period was significantly greater (p < 0.05) with ondansetron 4 mg compared with placebo. Prognostic factors for an increased likelihood of developing PONV in males included a history of motion sickness or previous PONV, patients undergoing nonorthopedic procedures, and surgeries lasting longer than one hour. Finally, 38 % of patients experiencing PONV perceived PONV to be as, or more debilitating than, the aftereffects of surgery itself.Conclusions: Ondansetron 4 mg was more effective than placebo in preventing PONV in male outpatients. Males at potential risk for developing PONV include: (1) those with a history of motion sickness and/or PONV; (2) patients undergoing nonorthopedic procedures; and (3) procedures lasting longer than one hour. Such patients may benefit from receipt of a prophylactic antiemetic. Postoperative nausea and vomiting has a debilitating effect that can be differentiated by patients from the effects of surgery itself.     

Efficacy of repeat intravenous dosing of ondansetron in controlling postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled multicenter trial.

STUDY OBJECTIVES: To compare repeat intravenous (i.v.) dosing of ondansetron 4 mg with placebo for the treatment of postoperative nausea and vomiting (PONV) in patients for whom prophylactic, preoperative ondansetron 4 mg i.v. was inadequate DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Ten outpatient surgical centers in the United States. PATIENTS: 2,199 male and female ASA physical status I, II, and III patients > or = 12 years old scheduled to undergo outpatient surgical procedures and receive nitrous oxide-based general anesthesia. INTERVENTIONS: Ondansetron 4 mg i.v. was administered to all patients before induction of general anesthesia. Patients who experienced PONV or requested antiemetic therapy within 2 hours after discontinuation of inhaled anesthesia were randomized (1:1) to either a repeat i.v. ondansetron 4 mg dose or placebo. MEASUREMENTS AND MAIN RESULTS: Of the 2,199 patients prophylactically treated with ondansetron 4 mg before anesthesia induction, 1,771 (80.5%) did not experience PONV or request antiemetic therapy during the 2 hours following discontinuation of anesthesia. Of the 428 patients who experienced PONV or requested antiemetic therapy during the same period, and were randomized to additional treatment (214 randomized to ondansetron, 214 randomized to placebo), the incidence of complete response (no emesis, no rescue medication, no study withdrawal) was similar for both ondansetron-randomized and placebo-randomized groups for the 2-hour (34% and 43%, respectively, p = 0.074) and 24-hour (28% and 32%, respectively, p = 0.342) postrandomization study periods. Repeat ondansetron dosing was not more effective than placebo in controlling either postoperative emesis or the severity/duration of postoperative nausea. The administration of an additional dose of ondansetron 4 mg postoperatively did not result in an increased incidence of adverse effects. CONCLUSIONS: In patients for whom preoperative prophylaxis with ondansetron 4 mg i.v. is not successful, a repeat dose of ondansetron 4 mg i.v. in the postanesthesia care unit does not appear to offer additional control of PONV.     

Effect of prophylactic ondansetron on postoperative nausea and vomiting after elective craniotomy.

This prospective, randomized, placebo-controlled, double-blind study was designed to evaluate the efficacy of ondansetron, a 5-HT3 antagonist, in preventing postoperative nausea and vomiting (PONV) after elective craniotomy in adult patients. The authors also tried to discover certain predictors for postcraniotomy nausea and vomiting. We studied 170 ASA physical status I and II patients, aged 15 to 70 years, undergoing elective craniotomy for resecting various intracranial tumors and vascular lesions. A standardized anesthesia technique and postoperative analgesia were used for all patients. Patients were divided into two groups and received either saline placebo (Group 1) or ondansetron 4 mg (Group 2) intravenously at the time of dural closure. Patients were extubated at the end of surgery and episodes of nausea and vomiting were noted for 24 hours postoperatively in the neurosurgical intensive care unit. Demographic data, duration of surgery, and anesthesia and analgesic requirements were comparable in both groups. Overall, a 24-hour incidence of postoperative emesis was significantly reduced in patients who received ondansetron compared with those who received a saline placebo (39% in Group 1 and 11% in Group 2, P = .001). There was a significant reduction in the frequency of emetic episodes and rescue antiemetic requirement in patients treated with ondansetron; however, ondansetron did not significantly reduce the incidence of nausea alone (14% in Group 2 vs 5% in Group 1, P = .065). Prophylactic ondansetron had a favorable influence on PONV outcome measures such as patient satisfaction and number needed to prevent emesis (3.5). Side effects were similar in both groups. We conclude that ondansetron 4 mg given at the time of dural closure is safe and effective in preventing emetic episodes after elective craniotomy in adult patients.     

A randomized controlled comparison of electro-acupoint stimulation or ondansetron versus placebo for the prevention of postoperative nausea and vomiting

In this study we evaluated the efficacy of electro-acupoint stimulation, ondansetron versus placebo for the prevention of postoperative nausea and vomiting (PONV). Patients undergoing major breast surgery under general anesthesia were randomized into active electro-acupoint stimulation (A), ondansetron 4 mg IV (O), or sham control (placement of electrodes without electro-acupoint stimulation; placebo [P]). The anesthetic regimen was standardized. The incidence of nausea, vomiting, rescue antiemetic use, pain, and patient satisfaction with management of PONV were assessed at 0, 30, 60, 90, 120 min, and at 24 h. The complete response (no nausea, vomiting, or use of rescue antiemetic) was significantly more frequent in the active treatment groups compared with placebo both at 2 h (A/O/P = 77%/64%/42%, respectively; P = 0.01) and 24 h postoperatively (A/O/P = 73%/52%/38%, respectively; P = 0.006). The need for rescue antiemetic was less in the treatment groups (A/O/P = 19%/28%/54%; P = 0.04). Specifically, the incidence and severity of nausea were significantly less in the A group compared with the other groups, and in the O group compared with the P group (A/O/P = 19%/40%/79%, respectively). The A group experienced less pain in the postanesthesia care unit, compared with the O and P groups. Patients in the treatment groups were more satisfied with their management of PONV compared with placebo. When used for the prevention of PONV, electro-acupoint stimulation or ondansetron was more effective than placebo with greater degree of patient satisfaction, but electro-acupoint stimulation seems to be more effective in controlling nausea, compared with ondansetron. Stimulation at P6 also has analgesic effects.     

Postoperative nausea and vomiting with special reference to risk factors and prevention in laparoscopic surgery

The current incidence, risk factors and prevention of postoperative nausea and vomiting (PONV) were prospectively evaluated in 1703 inpatients. The objectives of the study were: 1) to create a predictive model based on patient characteristics in order to enable the estimation of the risk for PONV, 2) to ascertain the antiemetic efficacy of prophylactic intravenous ondansetron in comparison with droperidol and placebo against PONV following laparoscopic surgery, and 3) to evaluate the antiemetic effectiveness of combining ondansetron with a low dose of droperidol in high-risk inpatients. The incidence of nausea and vomiting after common surgical procedures was high. In the recovery room, the overall incidence of nausea and vomiting was 18% and 5%, respectively, and over the whole 24-h observation period the respective figures were 52% and 25%. The most significant predictive factors associated with an increased risk for the symptoms were female sex, a previous history of postoperative nausea and vomiting, a history of motion sickness, a longer duration of surgery and non-smoking. Based on these five items, a risk score predicting nausea and vomiting was constructed with a moderately good discriminating power, as judged from the area under the receiver operating characteristic curve. Intravenous ondansetron 4 mg was ineffective in the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. A higher dose of prophylactic ondansetron 8 mg effectively reduced the incidence and alleviated the intensity of PONV in women scheduled to have laparoscopy for gynaecological and general surgical procedures, as compared with placebo. The antiemetic efficacy of prophylactic ondansetron 8 mg and droperidol 1.25 mg was similar as for overall nausea during the 24-h observation period, but ondansetron seemed to be slightly more efficacious in preventing vomiting. Both ondansetron and droperidol were well-tolerated with only minor side-effects. In a high-risk, female, inpatient laparoscopic population, with a mean estimated risk of 65% for PONV, prophylactically administered ondansetron 8 mg in combination with either a 0.75 mg or 1.25 mg dose of droperidol reduced the incidence of post-operative nausea to 35% and that of vomiting to 15% during the first 24 h after surgery. Of these drug combinations, the smaller dose of droperidol resulted in less postoperative sedation than the higher dose; both combinations being otherwise equally well-tolerated without serious adverse events. These results indicate that postoperative nausea and vomiting can, to some extent, be predicted by a few patient characteristics, and in laparoscopic surgery - which is associated with an increased risk for PONV - the incidence can be reduced with either a single dose of ondansetron or droperidol or a combination of these drugs.     

Cost-effectiveness of prophylactic antiemetic therapy with ondansetron, droperidol, or placebo

BACKGROUND: In an era of growing economic constraints on healthcare delivery, anesthesiologists are increasingly expected to understand cost analysis and evaluate clinical practices. Postoperative nausea and vomiting (PONV) are distressing for patients and may increase costs in an ambulatory surgical unit. The authors compared the cost-effectiveness of four prophylactic intravenous regimens for PONV: 4 mg ondansetron, 0.625 mg droperidol, 1.25 mg droperidol, and placebo. METHODS: Adult surgical outpatients at high risk for PONV were studied. Study drugs were administered intravenously within 20 min of induction of nitrous oxide-isoflurane or enflurane anesthesia. A decision-tree analysis was used to group patients into 12 mutually exclusive subgroups based on treatment and outcome. Costs were calculated for the prevention and treatment of PONV. Cost-effectiveness analysis was performed for each group. RESULTS: Two thousand sixty-one patients were enrolled. Efficacy data for study drugs have been previously reported, and the database from that study was used for pharmacoeconomic analysis. The mean-median total cost per patient who received prophylactic treatment with 4 mg ondansetron, 0.625 mg droperidol, 1.25 mg droperidol, and placebo were $112 or $16.44, $109 or $0.63, $104 or $0.51, and $164 or $51.20, respectively (P = 0.001, active treatment groups vs. placebo). The use of a prophylactic antiemetic agent significantly increased patient satisfaction (P < 0.05). Personnel costs in managing PONV and unexpected hospital admission constitute major cost components in our analysis. Exclusion of nursing labor costs from the calculation did not alter the overall conclusions regarding the relative costs of antiemetic therapy. CONCLUSION: The use of prophylactic antiemetic therapy in high-risk ambulatory surgical patients was more effective in preventing PONV and achieved greater patient satisfaction at a lower cost compared with placebo. The use of 1.25 mg droperidol intravenously was associated with greater effectiveness, lower costs, and similar patient satisfaction compared with 0.625 mg droperidol intravenously and 4 mg ondansetron intravenously.     

Postoperative nausea and vomiting in children and adolescents undergoing radiofrequency catheter ablation: a randomized comparison of propofol- and isoflurane-based anesthetics

In children, radiofrequency catheter ablation (RFCA) is typically performed under general anesthesia. With the use of volatile anesthetics, postoperative nausea and vomiting (PONV) are common, with an incidence of emesis as frequent as 60%. We tested the hypothesis that a propofol (PRO)-based anesthetic would have a less frequent incidence of PONV than an isoflurane (ISO)-based anesthetic. Patients were randomly assigned to receive either an ISO- or PRO-based anesthetic. Prophylactic ondansetron was given to all patients and droperidol was used as a rescue antiemetic postoperatively while PONV was monitored postoperatively for 18 h. The incidence of nausea, vomiting, use of rescue antiemetic drugs, and sedation scores were recorded. The cost for the anesthetic was also calculated. Fifty-six subjects were included in this study. The cumulative incidence of PONV was significantly more frequent in group ISO (63% nausea/55% emesis) compared with group PRO (21% nausea/6% emesis). After the administration of droperidol, further vomiting occurred in 70% of the patients in group ISO versus 0% of the patients in group PRO. We conclude that RFCA using ISO has a high PONV risk and the prophylactic use of ondansetron as well as antiemetic therapy with droperidol are ineffective. In contrast, a PRO-based anesthetic is highly effective in preventing PONV in children undergoing RFCA. IMPLICATIONS: In children undergoing radiofrequency catheter ablation and receiving prophylactic ondansetron, a frequent incidence (60%) of postoperative vomiting was observed under an isoflurane-based anesthetic, whereas the incidence was significantly reduced to a very low level (5%) under a propofol-based anesthetic.     

The Dose-Response Relation and Cost-effectiveness of Granisetron for the Prophylaxis of Pediatric Postoperative Emesis

Background: Postoperative nausea and vomiting (PONV) may delay discharge from hospital after ambulatory surgery. The antiserotonin agents, ondansetron and granisetron, provide effective prophylaxis against chemotherapy-induced and postoperative nausea and vomiting in adults, but are expensive. We determined the dose-response relation of granisetron and the financial impact of using this drug in preventing PONV after pediatric outpatient surgery.

Methods: In a randomized, double-blind, placebo-controlled study, 97 pediatric outpatients received a placebo or 10 or 40 micro gram [centered dot] kg sup -1 granisetron intravenously during a standardized anesthetic. Episodes of postoperative retching, vomiting, and times to discharge readiness were recorded. A decision analysis tree was used to divide each study group into nine mutually exclusive subgroups, depending on the incidence of PONV, need for rescue therapy, and the side effects of antiemetics. Costs and probabilities were assigned to each subgroup, and the cost-effectiveness ratio was determined by dividing the sum of these weighted costs by the number of patients free from both PONV and antiemetic side effects.

Results: Granisetron (40 micro gram [centered dot] kg sup -1 intravenously) was more effective than a placebo or 10 micro gram [centered dot] kg sup -1 granisetron in decreasing the incidence and frequency of postoperative emesis, both in the ambulatory surgery center and during the first 24 h. Patients receiving 40 micro gram [centered dot] kg sup -1 granisetron also had shorter times to discharge readiness compared with those receiving a placebo. Administering this dose of granisetron to all high-risk patients would cost the ambulatory care center an additional $99 (95% CI, range $89-$112) per emesis-free patient if nursing labor costs are excluded and $101 (95% CI, range $91-$113) if nursing costs are included.     

Patient-controlled Antiemesis: A Randomized, Double-Blind Comparison of Two Doses of Propofol versus Placebo

Background: The role of propofol for the management of postoperative nausea and vomiting (PONV) is not well established. This study determines the efficacy of small doses of propofol administered by patient-controlled device for the treatment of PONV.

Methods: Patients presenting for ambulatory surgery received a standardized general anesthetic. Those who experienced significant nausea or emesis within 1 h of arrival in the recovery room were randomized to receive repeated doses of propofol 20 mg (P-20), propofol 40 mg (P-40), or intralipid (placebo) on demand. Study medications (in equal volumes) were administered with a patient-controlled delivery device for 2 h. A lockout interval of 5 min between doses was used. The following parameters were assessed: nausea, vomiting, rescue antiemetic use, recovery profile, study drug administration history, and satisfaction with treatment.

Results: Sixty-nine patients participated in the study. Patient demographics were similar. The average nausea score for a patient in the P-20 and P-40 groups was 25% and 29% less, respectively, compared with placebo during the study period (P < 0.05). This difference was apparent 15 min after initiation of therapy. More placebo patients vomited (P-20, 12%; P-40, 23%; placebo, 56%; P = 0.003) and needed rescue antiemetics (P-20, 17%; P-40, 23%; placebo, 70%; P = 0.001) compared with treatment groups. Sedation scores were similar between groups. Propofol-treated patients had shorter stays in the post-anesthesia care unit (PACU; P-20, 131 +/- 35 min [mean +/- SD]; P-40, 141 +/- 34 min; placebo, 191 +/- 92 min; P = 0.005) and higher satisfaction with their control of PONV than placebo (P < 0.01).     

Multimodal antiemetic management prevents early postoperative vomiting after outpatient laparoscopy

Because no completely effective antiemetic exists for the prevention of postoperative nausea and vomiting (PONV), we hypothesize that a multimodal approach to management of PONV may reduce both vomiting and the need for rescue antiemetics in high-risk patients. After IRB approval, women undergoing outpatient laparoscopy were randomized to one of three groups. Group I (n = 60) was managed by using a predefined multimodal clinical care algorithm. Patients undergoing the same surgical procedure who received a standard balanced outpatient anesthetic with ondansetron 4 mg (Group II, n = 42) or placebo (Group III, n = 37) prophylaxis were chosen to establish baseline incidence of nausea and vomiting. None of the Group I patients vomited before discharge, compared with 7% in Group II (P = 0.07) and 22% in Group III (P = 0.0003). However, one patient (2%) in Group I required treatment for symptoms in the postanesthesia care unit, compared with 24% in Group II (P<0.0001) and 41% in Group III (P< 0.0001). Time to discharge-ready was significantly shorter in Group I (128, 118-139 min; mean, 95% confidence interval) versus Group II (162, 145-181 min; P = 0.0015) and Group III (192, 166-222 min; P = 0.0001). Patient satisfaction with control of PONV was not different between Group I and Group II. Return to normal daily activity and overall satisfaction were not different among groups. Multimodal management resulted in a 98% complete response rate and a 0% incidence of vomiting before discharge; however, this improvement did not result in an increased level of patient satisfaction when compared with routine monotherapy prophylaxis. We conclude that both multimodal management and routine monotherapy antiemetic prophylaxis resulted in an increased level of patient satisfaction than symptomatic treatment in this high-risk population.     

Prophylactic antiemetic therapy with ondansetron,tropisetron, granisetron and metoclopramide in patients undergoing laparoscopic cholecystectomy: a randomized,double-blind comparison with placebo

Purpose

Postoperative nausea and vomiting (PONV) is a distressing adverse effect of general anaesthesia. The aim of the current study was to compare the antiemetic activity of different 5-hydroxytryptamine₃ receptor antagonists with that of metoclopramide and placebo.

Methods

In a prospective, randomized, double-blind study we have compared the antiemetic activity of the prophylactic administration of ondansetron 4 mg, tropisetron 5 mg and granisetron 3 mg with that of metoclopramide 10 mg and placebo in 132 patients undergoing laparoscopic cholecystectomy. All study drugs and placebo were given as a short iv infusion ten minutes before the induction of anaesthesia. Perioperative anaesthetic care was standardized in all patients. Nausea and vomiting were assessed by direct questioning of the patient at 1, 4, 9, 12, 18 and 24 hr after recovery from anaesthesia. If patients experienced nausea and/or vomiting, rescue antiemetic treatment (metoclopramide 10 mg iv) was administered.

Results

For the 24-hr recovery period after surgery, the percentages of emesis-free patients were 65.5%, 52%, 48%, 29.2% and 27.6% in the ondansetron, granisetron, tropisetron, metoclopramide and placebo groups, respectively. Prophylactic antiemetic treatment with ondansetron resulted in a lower incidence (P = 0.02) of PONV than with metoclopramide or placebo. The times at which rescue antiemetic was first received were longer (P < 0.01) in ondansetron group than in the placebo and metoclopramide groups. There were no statistical differences between ondansetron, tropisetron and granisetron groups.

Conclusions

Ondansetron, when given prophylactically resulted in a significantly lower incidence of PONV than metoclopramide and placebo. Metoclopramide was ineffective.     

Prevention of postoperative nausea and vomiting with metoclopramide, droperidol and ondansetron: a randomized, double-blind comparison with placebo in ambulatory surgery

In order to compare the efficacy of metoclopramide, droperidol and two different doses of ondansetron in the prevention of postoperative nausea and vomiting (PONV) after ambulatory surgery, a prospective, randomized, double-blind, placebo-controlled study was performed in 264 patients. The incidence of PONV was 6% and no antiemetic was more effective than placebo in preventing this complication during the 24 h after surgery.     

A comparison of the costs and efficacy of ondansetron versus dolasetron for antiemetic prophylaxis

The optimal dose and timing of 5-HT(3) antagonist administration for prophylaxis against postoperative nausea and vomiting (PONV) remains controversial. Although 5-HT(3) antagonists seem to be most effective when administered near the end of surgery, there are no data on the comparative efficacy or costs associated with the 5-HT(3) antagonists dolasetron and ondansetron when administered at the end of the operation. In this double-blinded study, 200 outpatients undergoing otolaryngologic procedures with a standardized general anesthetic received 4 (O4) or 8 mg (O8) of ondansetron or 12.5 (D12.5) or 25 mg (D25) of dolasetron IV within 30 min before the end of surgery. A blinded observer recorded the emetic episodes, maximum nausea score, recovery room resource and drug use, nursing time spent managing PONV, times to achieve discharge criteria from the Phase 1 and 2 recovery units, postdischarge emesis, and patient satisfaction. Total costs were calculated by using the perspective of a free-standing surgicenter. There were no differences in patient demographics, incidence of PONV, need for rescue medications, time spent in the recovery areas, unanticipated hospital admissions, or patient satisfaction among the four treatment groups. The mean total costs (95% confidence intervals) to prevent PONV in one patient were lowest in the D12.5 group: $23.89 (17.18-28.79) vs $37.81 (30.29-45.32), $33.91 (28.92-39.35), and $75.18 (61.13-89.24) for D25, O4, and O8, respectively. Excluding nursing labor costs did not alter this finding: $18.51 (14.18-22.85), $34.77 (28.03-41.49), $31.77 (28. 92-39.35), and $71.76 (58.17-85.35) for D12.5, D25, O4, and O8, respectively. We conclude that 12.5 mg of dolasetron IV is more cost effective than 4 mg of ondansetron IV for preventing PONV after otolaryngologic surgery and is associated with similar patient satisfaction. Implications: When administered at the end of surgery, 12.5 mg of dolasetron IV is as effective as 25 mg of dolasetron IV, 4 mg of ondansetron IV, and 8 mg of ondansetron IV in preventing emetic symptoms after otolaryngologic surgery and was associated with similar patient satisfaction at a reduced cost. There were no differences in the antiemetic efficacy of the 4 and 8 mg doses of ondansetron.     

Additive anti-emetic efficacy of prophylactic ondansetron with droperidol in out-patient gynecological laparoscopy

PURPOSE: To determine the efficacy of ondansetron and droperidol, alone and in combination, administered for prophylaxis of postoperative nausea and vomiting (PONV) in women undergoing general anesthesia for outpatient gynecological laparoscopy. METHODS: Following Institutional Ethics Board approval and patient consent, 160 female out- patients scheduled for laparoscopy were randomly allotted in a double-blind fashion to receive: i) saline (placebo), ii) 4 mg ondansetron, iii) 1.25 mg droperidol, or iv) 4 mg ondansetron and 1.25 mg droperidol combination intravenously on induction. Following a standardized general anesthesia, patients were interviewed and assessed for PONV at various times. RESULTS: During the first 24 hr after surgery, the incidence of PONV in the placebo group was 71%. This was reduced to 61% with droperidol alone (P = 0.334), to 46% with ondansetron alone (P = 0.027), and to 23% with the combination group (P<0.001). A statistically significant difference was observed between combination and droperidol (P<0.001) and between combination and ondansetron (P = 0.036). There were fewer requests for rescue medication from the combination group (7.7%) than from the ondansetron and placebo groups. CONCLUSION: The results of this study suggest that the combination of 4 mg ondansetron and 1.25 mg droperidol is more efficacious as a prophylactic anti-emetic than either agent alone during the 24 hr post-surgery. This additive effect may be due to the different mechanisms of action of ondansetron and droperidol.