Placebo-controlled comparison of dolasetron and metoclopramide in preventing postoperative nausea and vomiting in patients undergoing hysterectomy

BACKGROUND AND OBJECTIVE: In a randomized, placebo-controlled, double-blind trial, we compared the efficacy of dolasetron and metoclopramide in preventing postoperative nausea and vomiting in women undergoing hysterectomy. METHODS: Patients were allocated randomly to one of three groups: group A (n = 50) received 50 mg dolasetron orally, group B (n = 50) received 20 mg metoclopramide intravenously and placebo orally, group C (n = 50) received placebo orally. If patients complained of retching or vomiting, or if patients demanded an antiemetic, 1.25 mg droperidol was administrated intravenously. To quantify postoperative nausea and vomiting the following score was used: 0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting. The Raatz test was used to analyse postoperative nausea and vomiting (PONV) scores. RESULTS: Dolasetron reduced the postoperative nausea and vomiting score significantly (P < 0.02 vs. metoclopramide; P < 0.0001 vs. placebo). Metoclopramide also reduced the postoperative nausea and vomiting score (P < 0.02 vs. placebo). Fisher's exact test showed a significant reduction of vomiting in the dolasetron group compared with metoclopramide-treated patients (P < 0.007) and placebo-treated patients (P < 0.000006) and a significantly lower rate of nausea in comparison to the placebo group (P < 0.009). There were no significant differences between the metoclopramide and the placebo groups (in Fisher's exact test). The use of postoperative droperidol per patient was significantly lower in the dolasetron group (P < 0.04 vs. metoclopramide; P < 0.0001 vs. placebo) than in the metoclopramide (P < 0.02 vs. placebo) and in the placebo groups. CONCLUSIONS: Oral dolasetron is more effective than either metoclopramide given intravenously or placebo for preventing vomiting after hysterectomy. It also was significantly superior to either metoclopramide or placebo concerning the PONV score and the need for droperidol rescue.     

The effect of timing of dolasetron administration on its efficacy as a prophylactic antiemetic in the ambulatory setting

Dolasetron (12.5 mg IV) is effective in both preventing and treating postoperative nausea and vomiting (PONV) after ambulatory surgery. However, the optimal timing of dolasetron administration and its effect on the patient's quality of life after discharge have not been established. One-hundred-five healthy, consenting women undergoing gynecologic laparoscopic procedures with a standardized general anesthetic technique were enrolled in this randomized, double-blinded study. Group 1 received dolasetron 12.5 mg IV 10-15 min before the induction of anesthesia; Group 2 received dolasetron 12.5 mg IV at the end of the laparoscopy (79 +/- 48 min later than Group 1); and Group 3 received dolasetron 12.5 mg IV at the end of anesthesia (93 +/- 52 min later than Group 1). The incidence of PONV, complete responses (defined as no emetic episodes and no rescue medication within the 24-h period after anesthesia), recovery profiles, and patient satisfaction were recorded. In the postanesthesia care unit and during the 24-h follow-up period, the incidence of nausea and vomiting, as well as the need for rescue antiemetics, did not differ significantly among the three groups. The percentages of patients with complete responses to the study drug within the first postoperative 24 h were also similar in all three groups (55%, 59%, and 52% for Groups 1, 2, and 3, respectively). The early and intermediate recovery profiles, including resumption of a normal diet and patient satisfaction with the control of PONV, were not different among the three study groups. Dolasetron 12.5 mg IV administered before the induction of anesthesia is as effective as dolasetron given at the end of laparoscopy or at the end of anesthesia in preventing PONV after outpatient laparoscopy. IMPLICATIONS: The timing of dolasetron administration appears to have little effect on its efficacy when administered as a prophylactic antiemetic in the ambulatory setting.     

Prophylaxe von Übelkeit und Erbrechen nach Pelviskopien Dolasetron oder MCP im Vergleich zu Plazebo

BACKGROUND: Gynaecological surgery including laparoscopy is frequently associated with PONV. Therefore, choosing an anaesthetic with only little side effects in operations eligible for outpatient surgery is at least as important as applying anaesthetics that enable fast-tracking. STUDY GOAL: To assess the incidence and severity of PONV after balanced desflurane-N(2)O-anaesthesia and to compare the antiemetic efficacy of dolasetron or metoclopramide versus placebo. METHODS: 120 ASA physical status I and II women aged 18 to 55 scheduled for elective laparoscopic surgery were enrolled. Anaesthesia was standardized: fentanyl (2 microg/kg), etomidate (0. 25 mg/kg) and succinylcholine (1 mg/kg) for induction and desflurane 3-5% et along with 30% O(2) in N(2)O, fentanyl (max. 0.1 mg/h) and cis-atracurium for maintenance. Patients were randomly allocated to receive one of the following: dolasetron 12.5 mg (group-D), metoclopramide 10 mg (group-M) or placebo (group-P). RESULTS: Within the first 24 h, postoperative nausea (PON) and postoperative vomiting (POV) were reduced significantly in group D (38%/19%) and group M (36%/27%) compared to group P (69%/56%). Furthermore, PON and POV proved to be less intense in groups D and -M compared to group P: Episodes of severe nausea were recorded 17 times in 10 patients (17/10) in group P, compared to 5/4 in group M and 5/3 in group D, episodes of repeated vomiting 13 times in 8 patients (13/8) in group P, compared to 2/2 in group M and 2/1 in group D. CONCLUSIONS: Our results confirm the increased incidence of PONV after gynaecological laparoscopic surgery under balanced anaesthesia compared to the predicted rates. Both dolasetron and metoclopramide proved to be effective prophylactic measures. Given a PONV-incidence of 38% in group D and 39% in group M, it is doubtful, whether the anaesthetic technique chosen in this study is the most suitable regimen for ambulatory gynaecological laparoscopies.     

Dimenhydrinate and metoclopramide alone or in combination for prophylaxis of PONV

PURPOSE: Dimenhydrinate and metoclopramide are inexpensive antiemetic drugs. Metoclopramide, especially, has been studied extensively in the past, but there are no studies on the combination of both drugs for prevention of postoperative nausea and vomiting (PONV). METHODS: One hundred and sixty male inpatients undergoing endonasal surgery were randomized to receive one of four antiemetic regimens in a double-blind manner: placebo, 1 mg x kg(-1) dimenhydrinate, 0.3 mg x kg(-1) metoclopramide, or the combination of both drugs was administered after induction of anesthesia. Patients received a second dose of these drugs six hours after the first administration to mitigate their short half-life. Standardized general anesthesia included benzodiazepine premedication, propofol, desflurane in N2O/O2 vecuronium, and a continuous infusion of remifentanil. Postoperative analgesia and antiemetic rescue medication were standardized. Episodes of vomiting, retching, nausea, and the need for additional antiemetics were recorded for 24 hr. The incidences of PONV were analyzed with Fisher's Exact test and the severity of PONV (rated by a standardized scoring algorithm) with the Jonckheere-Terpestra-test. RESULTS: The incidence of patients free from PONV was 62.5% in the placebo-group and increased to 72.5% in the metoclopramide-group (P = 0.54), 75.0% in the dimenhydrinate-group (P = 0.34), and 85.0% in the combination- group (P = 0.025). In the latter group, the severity of PONV was reduced compared with placebo treatment (P = 0.017; Jonckheere-Terpestra-test). CONCLUSION: Dimenhydrinate and metoclopramide were ineffective in reducing the incidence and the severity of PONV. Their combination reduced the incidence of PONV compared with placebo.     

Dolasetron for preventing postanesthetic shivering.

We designed this study to assess the efficacy of dolasetron compared with clonidine and placebo in prophylaxis of postanesthetic shivering. We included 90 patients undergoing elective abdominal or urologic surgery. The patients were randomly assigned to one three groups (each group n = 30) using a double-blinded study protocol: Group A received 12.5 mg dolasetron, Group B 3 microg/kg clonidine, and Group C saline 0.9% as placebo. The medication was given after the induction of anesthesia. Postanesthetic shivering was judged by using a five-point scale. In the Clonidine group, 86.6% showed no shivering, whereas in the Dolasetron and Placebo groups, only 63.3% and 66.6%, respectively, were symptom free. Only clonidine, but not dolasetron, significantly reduced the incidence and the severity of shivering. We conclude that clonidine is effective in preventing shivering when given before surgery, whereas dolasetron, at the dose used, is not effective. IMPLICATIONS: Shivering, an irregular muscular fasciculation lasting longer than 15 s, is a common complication secondary to general anesthesia. We compared dolasetron with clonidine (an established antishivering drug) in the prevention of postanesthetic shivering. Dolasetron 12.5 mg was not effective.     

Reduced resource utilization in patients treated for postoperative nausea and vomiting with dolasetron mesylate. MCPR44 Study Group.

STUDY OBJECTIVE: To compare the effect of four different increasing increasing intravenous (i.v.) doses of dolasetron mesylate (12.5 mg, 25 mg, 50 mg, and 100 mg) versus placebo on resource utilization in patients who experienced and were treated for postoperative nausea and vomiting (PONV). DESIGN: Prospective, double-blind, randomized, multicenter study. PATIENTS: 620 ASA physical status I, II, and III male and female outpatients scheduled for surgery with general anesthesia. INTERVENTIONS: Patients who experienced postoperative nausea (duration > or = 5 min, self-reported as moderate to severe) or vomiting (> or = 1 emetic episode) within 2 hours of arrival in the postanesthesia care unit (PACU) were given a single i.v. dose of dolasetron mesylate (12.5 mg, 25 mg, 50 mg, or 100 mg) or placebo infused for at least 30 seconds. MEASUREMENTS AND MAIN RESULTS: Resource utilization in the PACU was assessed by time spent by nurses and/or doctors with patients for PONV and the use of hospital resources such as patient/bed linens and staff/emesis supplies. A significantly (p < 0.05) lower proportion of dolasetron-treated patients compared to placebo-treated patients required new patient/bed linens and staff/emesis supplies. Patients in the placebo group required the greatest amount of care from nurses and/or doctors compared to patients receiving dolasetron. CONCLUSIONS: Treatment with dolasetron can significantly decrease the utilization of emesis supplies and other hospital resources, including staff/emesis supplies and patient/bed linens. In addition, patients receiving dolasetron used fewer health care resources in time spent by hospital personnel than patients who were not treated with dolasetron.     

Ondansetron, granisetron, and dexamethasone compared for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy

BACKGROUND: Laparoscopic cholecystectomies are associated with an appreciably high rate of postoperative nausea and vomiting (PONV). This study was designed to compare the effectiveness of ondansetron, granisetron, and dexamethasone for the prevention of PONV in patients after laparoscopic cholecystectomy. METHODS: A total of 80 American Society of Anesthesiologists (ASA) physical class I-II patients scheduled for laparoscopic cholecystectomy were included in this randomized, double blind, placebo-controlled study. All patients received a similar standardized anesthesia and operative treatment. Patients were randomly divided into four groups (n = 20 each). Group 1, consisting of control patients, received 0.9% NaCl; group 2 patients received ondansetron 4 mg i.v.; group 3 patients received granisetron 3 mg i.v.; and group 4 patients received dexamethasone 8 mg i.v., all before the induction of anesthesia. Both nausea and vomiting were assessed during the first 24 h after the procedure. RESULTS: The total incidence of PONV was 75% with placebo, 35% with ondansetron, 30% with granisetron, and 25% with dexamethasone. The incidence of PONV was significantly less frequent in groups receiving antiemetics (p < 0.05). The differences between dexamethasone, granisetron, and ondansetron were not significant. CONCLUSIONS: Prophylactic dexamethasone 8 mg i.v. significantly reduced the incidence of PONV in patients undergoing laparoscopic cholecystectomy. Dexamethasone 8 mg was as effective as ondansetron 4 mg and granisetron 3 mg, and it was more effective than placebo.     

Intravenous dolasetron and ondansetron in prevention of postoperative nausea and vomiting: a multicenter, double-blind, placebo-controlled study

Background: Intravenous dolasetron mesilate has shown efficacy in the prevention of postoperative nausea and vomiting (PONV) when administered as a single dose prior to emergence from anesthesia. This trial compared intravenous dolasetron and ondansetron for the prevention of PONV when administered at induction of anesthesia.
Methods: This double-blind, placebo-controlled, multicenter trial randomized patients to one of four single IV treatments: placebo, 25 or 50 mg dolasetron, or 4 mg ondansetron. Efficacy was measured by complete response (0 emetic episodes and no rescue medication), nausea severity and patient satisfaction as measured on a visual analog scale (VAS), investigator's rating of nausea severity, and total response (complete response with no nausea [≤ mm VAS]).
Results: 514 patients at 24 sites were evaluated for efficacy. The 50 mg dolasetron and 4 mg ondansetron doses were statistically equivalent, and superior to placebo, for all efficacy measures. Complete response rates were 49%, 51%, 71% and 64% for placebo, 25 and 50 mg dolasetron, and ondansetron, respectively. Dolasetron 50 mg was statistically superior to 25 mg dolasetron for complete response, total response, VAS maximum nausea, time to first emetic episode, and patient satisfaction. The majority of adverse events were of mild-to-moderate intensity. Headache was the most frequently reported treatment-related adverse event with a 3%-5% incidence across treatments.
Conclusion: When given at induction of anesthesia, 50 mg intravenous dolasetron is equivalent to 4 mg ondansetron and superior to 25 mg dolasetron and placebo for the prevention of PONV. All treatments were safely administered and well tolerated.     

Low-dose dexamethasone effectively prevents postoperative nausea and vomiting after ambulatory laparoscopic surgery

PURPOSE: To evaluate the prophylactic effect of low-dose dexamethasone (5 mg) on postoperative nausea and vomiting (PONV) in women undergoing ambulatory laparoscopic surgery. Metoclopramide and saline served as controls. METHODS: One hundred twenty women (n=40 in each of the three groups) undergoing ambulatory laparoscopic tubal ligation under general anesthesia were enrolled in this randomized, double-blinded, placebo-controlled study. After tracheal intubation, group I received i.v. dexamethasone 5 mg, whereas groups II and III received i.v. metoclopramide 10 mg and saline, respectively. RESULTS: Patients in group I reported a lower incidence of PONV and requested less rescue antiemetics than those in group III during the first four postoperative hours (P <0.01). Patients in group I reported a lower incidence of PONV than those in groups II (P <0.05) and III (P <0.01) during the 24-hr postoperative period. Groups II and III did not differ from each other in the incidence of PONV and the proportion of patients who requested rescue antiemetics. CONCLUSION: Prophylactic iv dexamethasone 5 mg significantly reduces the incidence of PONV in women undergoing ambulatory laparoscopic tubal ligation. At this dose, dexamethasone is more effective than metoclopramide 10 mg or placebo.     

Comparison of the effectiveness of metoclopramide, ondansetron, and granisetron on the prevention of nausea and vomiting after laparoscopic cholecystectomy

BACKGROUND AND GOALS: A relatively high incidence of postoperative nausea and vomiting (PONV) occurs in patients undergoing a laparoscopic cholecystectomy. Prophylaxis of PONV is usually achieved with a single-dose antiemetic drug administered during the surgical procedure. The aim of the current study was to compare the antiemetic activity of different 5-hydroxytryptamine-3 receptor antagonists with that of metoclopramide. MATERIALS AND METHODS: In a randomised, double-blind study, 75 patients received the following: Group M, 10 mg metoclopramide; Group K, 40 mcg . kg(-1) granisetron; and Group Z, 15 mcg . kg(-1) ondansetron intravenously (IV) diluted in 20 cc 0.9% NaCl (n = 25 of each) i.v. immediately before the induction of anesthesia. The standard general anesthetic technique, which consisted of sevoflurane in air-oxygen and a fentanyl perfusion, was used. Nausea, vomiting, and safety assessments were performed continuously during the first 24 hours after anesthesia. RESULTS: There were no statistically significant differences for demographic data, American Society of Anesthesiology (ASA), operation duration, or anesthesia time among the three groups (P > 0.05). Evaluated nausea and vomiting scores in the first 3-hour period revealed that each of the drugs had a similar antiemetic effect (P > 0.05). Nausea and vomiting scores, evaluated between the 4-24 hours, also revealed that the group M scores were obviously higher than groups K and Z (P < 0.001). A comparison of incidences of dose administrations were statistically not significant among the groups (P > 0.05). CONCLUSIONS: Granisetron, when given prophylactically, resulted in a significantly lower incidence of PONV than metoclopramide and ondansetron, whereas metoclopramide was ineffective. Garnisetron may be an effective treatment in the proflaxy of PONV.     

Prophylactic antiemetics for laparoscopic cholecystectomy: droperidol, metoclopramide, and droperidol plus metoclopramide

BACKGROUND: Postoperative nausea and vomiting (PONV) is one of the most significant problems in laparoscopic surgery. The antiemetic effects of metoclopramide and droperidol used alone or in combination for prevention of PONV after laparoscopic cholecystectomy (LC) were assessed in this prospective, double blind, placebo controlled randomized study. PATIENTS AND METHODS: A series of 140 patients, ASA physical status I or II, were included in the study. Patients were randomized to one of the following groups: 1, placebo; 2, metoclopramide 10 mg after the induction of anesthesia and placebo at 12 h postoperatively; 3, droperidol 1.25 mg after the induction of anesthesia and droperidol 1.25 mg at 12 h postoperatively; and 4, droperidol 1.25 mg plus metoclopramide 10 mg after the induction of anesthesia and droperidol 1.25 mg at 12 h postoperatively. Patients were observed for 24 hours for PONV, pain, need for rescue analgesics, and adverse events. RESULTS: Data were analyzed using the Student's t-test and chi-square test, with P < 0.05 considered statistically significant. The mean incidence of PONV was 54% with placebo, 42% with metoclopramide, 14% with two doses of droperidol alone, and 11% with a combination of metoclopramide plus droperidol. The patients receiving a combination of metoclopramide and droperidol had a significantly lower rate of PONV than those administered metoclopramide alone (P < 0.05) or placebo (P < 0.001). Those receiving two-dose droperidol alone also had a significantly lower incidence of PONV compared with metoclopramide (P < 0.05) and placebo (P < 0.001). There was no statistically significant difference between the metoclopramide and placebo groups. Sedation was significantly greater in patients administered droperidol 12 h postoperatively. CONCLUSION: The combination of metoclopramide and droperidol, and two-dose droperidol alone, were found to significantly decrease the incidence of PONV after LC, whereas metoclopramide alone proved inefficient.     

Timing of administration of dolasetron affects dose necessary to prevent postoperative nausea and vomiting

STUDY OBJECTIVE: To determine if the timing of administration affects the dose of dolasetron necessary to prevent postoperative nausea and vomiting (PONV). DESIGN: Pooled data from 8 randomized, multicenter, double-blind, placebo-controlled studies with common endpoints. SETTING: University hospital. PATIENTS: A total of 4,587 ASA physical status I, II, and III patients, including 4,124 females undergoing primarily gynecologic procedures and 463 males undergoing various procedures (i.e., thyroidectomy or orthopedic, ophthalmologic, urologic, ENT, or laparoscopic surgery). INTERVENTIONS: Balanced general anesthesia was used during all procedures. Patients received a dose of dolasetron either for prevention of PONV (25 or 50 mg IV at induction; 25, 50, 100, or 200 mg orally 1 to 2 hours pre-induction; or 12.5, 25, 50, or 100 mg IV at end of anesthesia) or for treatment of PONV (12.5, 25, 50, or 100 mg IV). One PONV prevention study had an ondansetron (comparator) group. MEASUREMENTS: Outcome measures over a 24-hour study period included complete response (defined as no vomiting/retching and no need for rescue medication), percentage of patients without nausea [defined as nausea visual analog scale (VAS) score < 5 mm], and maximum nausea according to VAS score. MAIN RESULTS: A 12.5-mg IV dose of dolasetron resulted in a complete response rate that was statistically significantly higher than placebo and comparable to higher dolasetron doses (25 mg to 100 mg IV) when administered either near the end of anesthesia for prevention of PONV or at the onset of symptoms for treatment of PONV. In contrast, when administered at induction of anesthesia, a statistically significant treatment response was observed with dolasetron 50 mg IV, but not at a lower dose. CONCLUSIONS: When dosed near the end of anesthesia, a 12.5 mg IV dose of dolasetron was comparable to higher doses administered at or before induction of anesthesia.     

The impact of isoflurane, desflurane, or sevoflurane on the frequency and severity of postoperative nausea and vomiting after lumbar disc surgery

STUDY OBJECTIVE: To test the hypothesis that anesthesia with the low-soluble inhalation anesthetics, sevoflurane, and desflurane, may result in a lower frequency and severity of postoperative nausea and vomiting (PONV) than anesthesia with isoflurane. DESIGN: Prospective, observational study. SETTING: Postoperative care unit and neurosurgical ward at a university hospital. PATIENTS: 625 ASA physical status I, II, and III patients undergoing elective lumbar disc surgery with general anesthesia were included in this study. INTERVENTIONS: Patients were enrolled sequentially to receive either 0.7%-1.2% isoflurane (year 2002), 3.5%-5.5% desflurane (year 2003), or 1.2%-1.9% sevoflurane (year 2004) for maintenance of anesthesia without nitrous oxide. Study personnel, general anesthesia management, and surgical technique remained unchanged over the three-year study period. MEASUREMENTS: Occurrence of PONV within 24 hours of the end of surgery was recorded. Secondary outcome measures were occurrence of multiple PONV episodes, maximum severity, time to the first PONV event, need for rescue medication, difference between the occurrence of PONV (indicator variable) and the expected risk of PONV (based on the Apfel score). MAIN RESULTS: Type of inhalation anesthetic had no influence on PONV frequency (9.3%, 11.2%, and 10.8% after isoflurane, desflurane, and sevoflurane, respectively; P = 0.8) or its severity (numerical rating scale, 4.5 +/- 2.0, 4.4 +/- 2.4, and 4.2 +/- 2.1; P = 0.9). Patients who received isoflurane experienced fewer early events but had a late peak of PONV frequency (P = 0.031). For every 10 minutes by which the total duration of the anesthesia exceeded the net time between incision and suture, the risk of PONV increased by a factor of 1.36 (95% confidence interval, 1.15-1.61; P < 0.001). CONCLUSIONS: There is no difference between the three inhalation anesthetics currently used with regard to frequency or severity of postoperative nausea, vomiting, or both.     

RETRACTED ARTICLE: Ramosetronvs granisetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy

PURPOSE: To compare the efficacy of ramosetron with granisetron for the prevention of postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy. METHODS: In a randomized, double-blind study, 80 female inpatients received 3 mg granisetron or 0.3 mg ramosetron i.v. (n=40 of each) at the completion of surgery The standardized anesthetic included isoflurane and nitrous oxide in oxygen. RESULTS: Complete response, defined as no PONV, during the first 24 hr (0-24 hr) after anesthesia was 85% with granisetron and 93% with ramosetron, respectively (P=0.241); the corresponding incidence during the next 24 hr (24-48 hr) after anesthesia was 63% and 90% (P=0.004). No clinically important adverse events due to the study drug were observed in any of the groups. CONCLUSION: Ramosetron was more effective than granisetron for prevention of PONV during 0-48 hr after anesthesia for laparoscopic cholecystectomy.     

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.     

Dolasetron decreases postoperative nausea and vomiting after breast surgery

In a randomized, placebo-controlled, double-blind trial, we compared the efficacy of dolasetron, dexamethasone, and metoclopramide in a preventing postoperative nausea and vomiting in women undergoing breast surgery. Patients were allocated randomly to one of four groups (20 patients each): group A received 12.5 mg dolasetron, group B received 8 mg dexamethasone, group C received 20 mg metoclopramide, and group D received placebo intravenously. If patients complained of retching or vomiting or if patients demanded an antiemetic, 1.25 mg droperidol was administered intravenously. To quantify postoperative nausea and vomiting, the following score was used: 0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting. Dolasetron and dexamethasone reduced the postoperative nausea and vomiting score significantly (p < 0.02 versus metoclopramide; p < 0.0001 versus placebo). Metoclopramide also reduced the postoperative nausea and vomiting score (p < 0.02 versus placebo). Fisher's exact test showed a significant reduction of vomiting in the dolasetron and dexamethasone groups compared with metoclopramide-treated patients (p < 0.007) and placebo-treated patients (p < 0.000006) and a significantly lower rate of nausea in comparison to the placebo group (p < 0.009). There were no significant differences between the metoclopramide and the placebo groups (using Fisher's exact test). The use of postoperative droperidol was significantly lower in both the dolasetron group (p < 0.04 versus metoclopramide; p < 0.0001 versus placebo) and dexamethasone group (p < 0.04 versus metoclopramide; p < 0.0001 versus placebo), as well as in the metoclopramide group (p < 0.02 versus placebo). Intravenous dolasetron and dexamethasone were equally effective and both are more effective than metoclopramide for preventing vomiting after breast surgery. Also both were significantly superior to either metoclopramide or placebo for postoperative nausea and vomiting and the need for droperidol rescue.     

Intrathecal addition of morphine to bupivacaine is not the cause of postoperative nausea and vomiting

Background and Objectives. Postoperative nausea and vomiting after anesthesia is an distressing side effect. This study was undertaken to determine to what extent spinal opioids contribute to postoperative nausea and vomiting (PONV) and secondly to how effectively metoclopramide can reduce the incidence of PONV after intrathecal administration of morphine. Methods. Patients were allocated to three groups all undergoing major joint surgery of the lower limb. In group 1 (n = 200), intrathecal anesthesia was assessed by administration of 20 mg bupivacaïne and 0.2 mg morphine. In Group 2 (n = 100) intrathecal anesthesia was assessed in the same way and in addition, 20 mg metoclopramide intramuscular during maintenence of anesthesia and a second dose of 20 mg metoclopramide was administered intramuscular after arrival at the recovery room. Finally, in group 3 (n = 100), intrathecal anesthesia was assessed after administration of 20 mg bupivacaïne. Results. The maximum PONV percentages were 41.1%, 32.7%, and 37% in groups 1, 2, and 3, respectively. The consumption of antiemetics was similar in all groups. The number of patients who needed one or more additional antiemetics during the first 24 hours after surgery was 112 (56.6%), 57 (58%), and 60 (60%) in groups 1, 2, and 3, respectively. Conclusions. Administration of metoclopramide did not reduce the overall incidence of PONV. Our study shows no relationship between the use of intrathecal morphine and the incidence of PONV during the first 24 hours postoperative.     

Pooled analysis of three large clinical trials to determine the optimal dose of dolasetron mesylate needed to prevent postoperative nausea and vomiting. The Dolasetron Prophylaxis Study Group

STUDY OBJECTIVE: To identify the maximally effective dolasetron dose (i.e., maximum efficacy with minimum adverse events) for prevention of postoperative nausea and vomiting (PONV) using the statistical power generated in a pooled patient sample from three large, nearly identical clinical trials. DESIGN: Three randomized, multicenter, placebo-controlled, double-blinded trials. SETTING: Trials 1, 2, and 3 enrolled patients at 10, 25, and 17 hospitals and/or surgical centers, respectively. PATIENTS: A total of 1,946 ASA physical status, I, II, and III patients. Trials 1 and 2 enrolled only female patients (n = 916) undergoing gynecologic surgery. Trial three enrolled 722 females (approximately 70% gynecologic surgeries) and 308 males (approximately 46% orthopedic surgeries) undergoing a variety of surgical procedures. INTERVENTIONS: All surgical procedures used balanced general anesthesia. Patients received 12.5, 25, 50, or 100 mg of the antiemetic, dolasetron, near the end of anesthesia. MEASUREMENTS AND MAIN RESULTS: Efficacy endpoints were identical and measured for 24 hours: complete response (no vomiting or rescue medication) and maximum nausea, reported using a 100-mm visual analog scale (VAS). Safety was assessed using adverse event reports, laboratory and electrocardiographic data, and vital signs. All four dolasetron doses produced significant increases in complete response and decreases in maximum VAS nausea compared with placebo (p < 0.01). No increased efficacy was observed with dolasetron doses higher than 12.5 mg. Safety was similar between each dolasetron dose and placebo. CONCLUSION: Dolasetron 12.5 mg, given near the end of anesthesia, is the maximally effective dose studied for preventing postoperative nausea and vomiting.     

Comparison of dexamethasone,metoclopramide, and their combination in the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy

Background Postoperative nausea and vomiting (PONV) are one of the most common complaints following anesthesia and surgery. This study was designed to evaluate the efficacy of dexamethasone, metoclopramide, and their combination to prevent PONV in patients undergoing laparoscopic cholecystectomy. Methods A total of 160 ASA physical status I and II patients were included in this randomized, double blind, placebo-controlled study. Patients were randomly assigned to 4 groups (n = 40 each): group 1 consisting of control patients administered 0.9% NaCl; group 2 patients received metoclopramide 10 mg just before the end of anesthesia; group 3 patients received dexamethasone 8 mg after the induction of anesthesia; and group 4 patients received dexamethasone 8 mg after the induction of anesthesia and metoclopramide 10 mg before the end of anesthesia. The incidence of PONV, mean visual analog pain scores at rest and on movement, time to the first request for analgesia, side effects, and well-being score were recorded during the first 24 h postoperatively. Results Data were analyzed using one-way analysis of variance (ANOVA) and the χ² test, with p < 0.05 considered statistically significant. The total incidence of PONV was 60% with placebo, 45% with metoclopramide, 23% with dexamethasone, and 13% with the combination of dexamethasone plus metoclopramide. None of the dexamethasone plus metoclopramide group patients (p < 0.05 versus groups 1 and 2) and one dexamethasone group patient (p < 0.05 versus group 1) required antiemetic rescue, as compared with four patients in the metoclopramide group and six patients in the placebo group. Pain scores, the time to the first request for analgesia, and side effects were similar across the study groups. Conclusions Dexamethasone and the combination of dexamethasone plus metoclopramide were more effective in preventing PONV than metoclopramide and placebo.     

Effect of metoclopramide on mivacurium-induced neuromuscular block

In order to investigate the effect of metoclopramide on the duration of action of mivacurium, 45 patients were randomized into three groups. Group M10 (n = 15) and M20 (n = 15) received 10 and 20 mg of metoclopramide i.v., respectively, and group S (n = 15) received saline 2 min before induction of anesthesia with fentanyl, thiopental and mivacurium. Plasma cholinesterase activity (pCHE) was measured before induction of anesthesia and 2 min after injection of metoclopramide and saline. Neuromuscular block was monitored by a force transducer using train of four nerve stimulation. Anesthesia was maintained with isoflurane and N2O. Time to recovery of a twitch height of 90% was significantly prolonged in group M10 and M20 (44 +/- 15 and 57 +/- 10 min) as compared to group S, 32 +/- 9 min, P < 0.05). A slight but significant decrease in pCHE was observed in group M20. Because of the risk of prolonged duration of action of mivacurium, neuromuscular blockade should always be monitored whenever metoclopramide is given before injection of mivacurium.