Prophylactic ondansetron in prevention of postoperative nausea and vomiting following pediatric strabismus surgery: a dose-response study

BACKGROUND: This study evaluated the antiemetic effectiveness, dose-response, and clinical usefulness of prophylactic ondansetron in the prevention of postoperative nausea and vomiting (PONV) in children undergoing strabismus repair. METHOD: The authors observed 180 children, American Society of Anesthesiologists physical status I or II, 2-12 yr of age, who were undergoing strabismus repair. After induction of anesthesia with halothane and nitrous oxide in oxygen or intravenous thiopental, children received either placebo (saline) or intravenous ondansetron in doses of 25, 50, 75, 100, and 150 /microg/kg (n = 30). The trachea was intubated and ventilation was controlled. Perioperative analgesic and fluid requirements were standardized. Episodes of nausea and vomiting were recorded for the first 24 h postoperatively. Data such as nonsurrogate (parental satisfaction scores and duration of postanesthesia care unit stay) and therapeutic (numbers needed to prevent and harm) outcome measures were collected. RESULTS: The incidences of PONV in the placebo and 25-, 50-, 75-, 100-, and 150-,microg/kg ondansetron groups were 83, 77, 47, 30, 30, and 27%, respectively. The incidence was less in the 75(P = 0.002), 100- (P = 0.002), and 150-microg/kg (P < 0.001) ondansetron groups compared with placebo. Duration of stay in the postanesthesia care unit was shorter in the 75-, 100-, and 150-microg/kg ondansetron groups (P < 0.002) compared with the placebo group. Parental assessment scores for the child's perioperative experience and the positive number needed to prevent PONV were also better and favorable in the 75-, 100-, and 150-microg/kg ondansetron groups compared with the placebo group. The incidence (P > 0.99) and severity (P = 0.63) of PONV were similar in the 75- and 150-microg/kg ondansetron groups. Surrogate, nonsurrogate, and therapeutic outcome measures revealed that 75 microg/kg ondansetron provided the same benefits as did 100 and 150 microg/kg. CONCLUSION: The routine prophylactic use of ondansetron at a dose of 75 microg/kg is as effective as 150 microg/kg in preventing PONV and improving the "true" outcome measures after strabismus repair in children.     

Prophylactic Ondansetron in Prevention of Postoperative Nausea and Vomiting following Pediatric Strabismus Surgery: A Dose-Response Study

Background: This study evaluated the antiemetic effectiveness, dose-response, and clinical usefulness of prophylactic ondansetron in the prevention of postoperative nausea and vomiting (PONV) in children undergoing strabismus repair.

Method: The authors observed 180 children, American Society of Anesthesiologists physical status I or II, 2-12 yr of age, who were undergoing strabismus repair. After induction of anesthesia with halothane and nitrous oxide in oxygen or intravenous thiopental, children received either placebo (saline) or intravenous ondansetron in doses of 25, 50, 75, 100, and 150 [mu]g/kg (n = 30). The trachea was intubated and ventilation was controlled. Perioperative analgesic and fluid requirements were standardized. Episodes of nausea and vomiting were recorded for the first 24 h postoperatively. Data such as nonsurrogate (parental satisfaction scores and duration of postanesthesia care unit stay) and therapeutic (numbers needed to prevent and harm) outcome measures were collected.

Results: The incidences of PONV in the placebo and 25-, 50-, 75-, 100-, and 150-[mu]g/kg ondansetron groups were 83, 77, 47, 30, 30, and 27%, respectively. The incidence was less in the 75- (P = 0.002), 100- (P = 0.002), and 150-[mu]g/kg (P < 0.001) ondansetron groups compared with placebo. Duration of stay in the postanesthesia care unit was shorter in the 75-, 100-, and 150-[mu]g/kg ondansetron groups (P < 0.002) compared with the placebo group. Parental assessment scores for the child's perioperative experience and the positive number needed to prevent PONV were also better and favorable in the 75-, 100-, and 150-[mu]g/kg ondansetron groups compared with the placebo group. The incidence (P > 0.99) and severity (P = 0.63) of PONV were similar in the 75- and 150-[mu]g/kg ondansetron groups. Surrogate, nonsurrogate, and therapeutic outcome measures revealed that 75 [mu]g/kg ondansetron provided the same benefits as did 100 and 150 [mu]g/kg.     

Postoperative nausea and vomiting after breast surgery: efficacy of prophylactic ondansetron and droperidol in a randomized placebo-controlled study

Postoperative nausea and vomiting (PONV) is a common adverse phenomenon following breast surgery. The efficacy of ondansetron and droperidol in preventing post-operative nausea and vomiting in women undergoing breast surgery was compared in this randomized, double-blind, placebo-controlled study. Altogether 207 women were randomly assigned to receive either a single intravenous dose of droperidol (1.25 mg) (n = 69), ondansetron (8 mg) (n = 67) or saline (n = 71) immediately after induction of general anaesthesia with thiopental, fentanyl, atracurium, nitrous oxide in oxygen and isoflurane. Complaints of nausea, vomiting and requests for rescue antiemetics were recorded during a 24-h period postoperatively. During the initial 2 h in the postanaesthesia care unit, the incidence of postoperative nausea and vomiting was 15%, 6% and 12% in the placebo, droperidol and ondansetron groups, respectively (NS). The incidence of post-operative nausea and vomiting during the first 24 h was 61%, 48% and 45% in the placebo, droperidol and ondansetron treatment groups, respectively (NS). Postoperative analgesic requirements and the length of stay in the post-anaesthesia care unit were equal in all three treatment groups. It is concluded that the intravenous pretreatment with single doses of ondansetron or droperidol did not substantially prevent postoperative nausea and vomiting after breast surgery.     

Combination of droperidol and ondansetron reduces PONV after pediatric strabismus surgery more than single drug therapy

BACKGROUND: Pediatric strabismus surgery is associated with a very high incidence of postoperative nausea and vomiting [(PONV) 44-88%]. Droperidol (10-75 microg kg(-1)) and ondansetron (50-150 microg kg(-1)) have shown variable success in reducing the incidence and severity of PONV. Combination of these two drugs has shown promising results. This randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of the combination of these two drugs in reducing the incidence and severity of PONV in pediatric strabismus surgery. METHODS: After institutional approval and parental informed consent, 240 children of ASA physical status I and II of either sex, aged 1-15 years were included in this study. None of the children received any premedication and a standardized anesthesia technique was used for all the children. They were prospectively randomized to one of the four treatment groups. Group PP received normal saline placebo intravenously after induction and at the end of the procedure. Group DP received droperidol 25 microg kg(-1) after induction and normal saline at the end. Group OP received ondansetron 150 microg kg(-1) after induction and saline at the end. Group DO received droperidol 15 microg kg(-1) after induction and ondansetron 100 microg kg(-1) at the end. RESULTS: Combination prophylaxis resulted in a lower incidence of PONV (13%) as compared to placebo (62.5%, P<0.001), ondansetron (37%, P<0.001), or droperidol (32%, P<0.01). CONCLUSION: Droperidol 15 microg kg(-1) in combination with ondansetron 100 microg kg(-1), administered at the induction and end of the operative procedure respectively, is more effective than either drug given individually in reducing the incidence of PONV after strabismus surgery.     

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.     

Inspired oxygen fraction of 0.8 compared with 0.4 does not further reduce postoperative nausea and vomiting in dolasetron-treated patients undergoing laparoscopic cholecystectomy

Background. Postoperative nausea and vomiting (PONV) is oneof the most frequent complications after general anaesthesia.Single-dose antiemetic prophylaxis has limited efficacy in high-riskpatients. Adding a simple potential antiemetic approach, suchas increasing the inspired oxygen fraction, to the antiemeticportfolio would preserve pharmacological interventions for treatmentof symptoms in the postoperative period. However, the antiemeticeffect of a high inspired oxygen fraction is still discussedcontroversially. The aim of the study was to evaluate whetheran inspired oxygen fraction of 0.8 decreases PONV in patientsreceiving the 5-HT₃-antagonist dolasetron. Methods. In a randomized, placebo-controlled, double-blindedtrial we studied 377 patients (ASA I–III) undergoing electivelaparoscopic cholecystectomy. Induction of anaesthesia was standardized,including thiopental fentanyl and cis-atracurium. For all patientsthe individual risk for PONV was calculated using the Koivurantascore and all patients received 12.5 mg dolasetron i.v. beforesurgery. Patients were allocated randomly to one of three groups:Group A (n=125) received 80% oxygen in air, Group B (n=125)40% oxygen in air and Group C (n=127) 40% oxygen in nitrousoxide. Postoperative nausea, postoperative vomiting (PV), ornausea, vomiting, or both (PONV) was assessed in the early (0–4h) and overall postoperative period (0–24 h) by an anaesthesiologistunaware of patient allocation. Results. There was a significantly lower incidence of PONV andPV in Groups A (PONV: 11.2%; PV: 3.2%) and B (PONV: 10.4%; PV:3.2%) compared with Group C (PONV: 26.7%; PV: 13.3%), but therewere no significant differences between Groups A and B. Conclusions. An inspired oxygen fraction of 0.8 does not furtherdecrease PONV or vomiting in dolasetron-treated patients undergoinglaparoscopic cholecystectomy. The lower incidence of PONV inGroups A and B compared with Group C is most likely caused bythe omission of nitrous oxide.      

枢复宁预防全麻腹部手术后恶心和呕吐的临床研究

全麻患者术后常易发生恶心、呕吐，枢复宁有抗呕吐作用。随机选择１００例腹部外科手术患者，分为枢复宁组（４ｍｇ，ｎ＝５０）和安慰剂组（生理盐水，ｎ＝５０），诱导前静注枢复宁或安慰剂，注速１分钟，双盲法观察术后２４小时抗恶心、呕吐效果及副作用。结果表明，用药组恶心、呕吐发生率（１８％，０）明显低于安慰剂组（５０％，４０％）（Ｐ＜０．０１），两组患者的平均动脉压、经皮血氧饱和度，呼吸频率和心率，血液成分，肝、肾功能无明显改变。因此，枢复宁适用于腹部外科患者术后恶心、呕吐的防治。     

Ondansetron is no more effective than supplemental intraoperative oxygen for prevention of postoperative nausea and vomiting

Supplemental oxygen maintained during and for 2 h after colon resection halves the incidence of nausea and vomiting. Whether supplemental oxygen restricted to the intraoperative period is sufficient remains unknown. Similarly, the relative efficacy of supplemental oxygen and ondansetron is unknown. We tested the hypothesis that intraoperative supplemental oxygen reduces the incidence of postoperative nausea and vomiting. Patients (n = 240) undergoing gynecological laparoscopy were given a standardized isoflurane anesthetic. After induction, they were randomly assigned to the following three groups: routine oxygen administration with 30% oxygen, balance nitrogen (30% Oxygen group), supplemental oxygen administration with 80% oxygen, balance nitrogen (80% Oxygen group), and Ondansetron 8 mg (immediately after induction), combined with 30% oxygen, balance nitrogen (Ondansetron group). The overall incidence of nausea and/or vomiting during the initial 24 postoperative h was 44% in the patients assigned to 30% oxygen and 30% in the Ondansetron group, but only 22% in those given 80% oxygen. The incidence was thus halved by supplemental oxygen and was significantly less than with 30% oxygen. There were, however, no significant differences between the 30% oxygen and ondansetron groups, or between the ondansetron and 80% oxygen groups. We conclude that supplemental oxygen effectively prevents postoperative nausea and vomiting after gynecological laparoscopic surgery; furthermore, ondansetron is no more effective than supplemental oxygen. Implications: Supplemental oxygen reduces the risk of postoperative nausea and vomiting (PONV) as well or better than 8 mg of ondansetron. Because oxygen is inexpensive and essentially risk-free, supplemental oxygen is a preferable method of reducing PONV.     

Ondansetron Prophylaxe und Therapie von Übelkeit und Erbrechen nach größeren gynäkologischen Eingriffen Ergebnisse einer nationalen Multizenterstudie

This investigation was conducted as a national multicenter study to evaluate effectiveness and safety of prophylactic and therapeutic ondansetron for postoperative nausea and vomiting (PONV) in major gynaecological surgery. Methods: 387 patients were randomised to receive either ondansetron 8 mg or placebo i.v. prior to anaesthesia induction. Anaesthesia was performed with a volatile anaesthetic, nitrous oxide and opioids. Established PONV was treated with ondansetron 4 mg i.v.. Postoperative evaluation included time, duration and severeness of nausea and vomiting in the first 24 h after the operation. Results: In the study period the incidence of emesis was 35% after prophylactic ondansetron and 58% after placebo (p<0.01). Nausea occurred in 49% and 64% respectively (p<0.01). 28% after prophylactic ondansetron and 48% after placebo required ondansetron therapy (p<0.01). The number of adverse events was small in total and comparable for both groups. Conclusion: Our investigation proves the efficiency of ondansetron 8 mg prior to induction of anaesthesia in preventing PONV. Furthermore, our results demonstrate the safety of the drug for prophylaxis and therapy.     

Comparison of ondansetron and droperidol in the prevention of postoperative nausea and vomiting after laparoscopic surgery in women

Background : Women undergoing laparoscopic surgery are susceptible to postoperative nausea and vomiting (PONV). Ondansetron and droperidol are useful antiemetics. This study was designed to ascertain primarily the relative difference in efficacy of ondansetron and droperidol and secondarily between these drugs and placebo in the prevention of PONV after laparoscopic surgery. Methods : The prophylactic antiemetic efficacy of ondansetron and droperidol was compared in a prospective, randomised, double–blind, placebo–controlled trial of 439 female inpatients scheduled for laparoscopic surgery. During induction of standardised general anaesthesia the patients received intravenously either ondansetron 8 mg (n=195), droperidol 1.25 mg (n=193) or placebo (n=51). The occurrence of nausea, vomiting, sideeffects and the need for rescue antiemetic medication were recorded for 24 h postoperatively. Results : The proportion of patients with nausea was 48%, 50% and 67% in the ondansetron, droperidol and placebo groups, respectively; with a significant difference when both ondansetron (P=0.02) and droperidol (P=0.04) were compared with placebo. Vomiting occurred in 18%, 26% and 37% of the patients in the three groups, respectively (P=0.05 between ondansetron and droperidol, P=0.004 between ondansetron and placebo, P=0.16 between droperidol and placebo). The proportion of patients given rescue medication was 34%, 28% and 49%, respectively (P=0.23 for ondansetron and droperidol, P=0.07 for ondansetron and placebo, P=0.007 for droperidol and placebo). During early recovery the patients treated with ondansetron were significantly more alert than after droperidol. Serious side–effects were not observed. Headache was significantly more common after ondansetron than after droperidol treatment. Conclusions : The efficacy of prophylactic ondansetron and droperidol in reducing postoperative nausea associated with laparoscopic surgery in female inpatients was similar, but ondansetron appeared to be slightly more efficient than droperidol in preventing vomiting. Ondansetron and droperidol were both significantly better than placebo in the prophylaxis of PONV.     

A singleiv dose of ondansetron 8 mg prior to induction of anaesthesia reduces postoperative nausea and vomiting in gynaecological patients

The effect of a single intravenous dose of ondansetron in preventing postoperative nausea and emesis (retching and vomiting) (PONV) was investigated in a randomized, double-blind, placebo-controlled, multicentre, international study. Women of ASA class I–III, requiring gynaecological laparotomy, vaginal hysterectomy, or major vaginal surgery were selected for study. Two hundred and thirty-five received placebo, 231 received 1 mg ondansetron, 228 received 8 mg ondansetron and 229 received 16 mg ondansetron, as an infusion over five minutes before the induction of anaesthesia. A standardized balanced anaesthetic technique was employed. This consisted of premedication with either diazepam or temazepam, thiopentone induction, maintenance with nitrous oxide in oxygen supplemented with enflurane or isoflurane, intraoperative analgesia with fentanyl, neuromuscular blockade with any choice of agent and reversal with neostigmine and atropine. Postoperative analgesia was achieved with morphine, and prochlorperazine or metoclopramide were given if a rescue antiemetic was required. A greater percentage of patients in the 8 mg and 16 mg ondansetron groups experienced no postoperative emesis (44% and 39% respectively) than in the placebo and 1 mg ondansetron groups (29% and 28% respectively) for the first 24 hr postoperative period (8 mg vs placebo and 1 mg: P ≤ 0.001; 16 mg vs placebo: P < 0.05; 16 mg vs 1 mg: P < 0.05). Similarly, the percentage of patients who did not experience postoperative nausea were 20%, 26%, 31% and 28% for the placebo, 1 mg, 8 mg and 16 mg ondansetron treatment groups, respectively (8 mg and 16 mg vs placebo P < 0.05). Overall, the incidences of adverse events in the ondansetron and placebo groups were similar. It is concluded that intravenous ondansetron, at doses of 8 mg and 16 mg, is both well tolerated and effective in preventing postoperative nausea and emesis, and no greater benefit was observed with the 16 mg dose in comparison with the 8 mg dose.     

A comparison of three antiemetic combinations for the prevention of postoperative nausea and vomiting

In this study we compared the efficacy and safety of three antiemetic combinations in the prevention of postoperative nausea and vomiting (PONV). Ninety ASA status I-II women, aged 18-65 yr, undergoing general anesthesia for major gynecological surgery, were included in a prospective, randomized, double-blinded study. A standardized anesthetic technique and postoperative analgesia (intrathecal morphine plus IV patient-controlled analgesia (PCA) with morphine) were used in all patients. Patients were randomly assigned to receive ondansetron 4 mg plus droperidol 1.25 mg after the induction of anesthesia and droperidol 1.25 mg 12 h later (Group 1, n = 30), dexamethasone 8 mg plus droperidol 1.25 mg after the induction of anesthesia and droperidol 1.25 mg 12 h later (Group 2, n = 30), or ondansetron 4 mg plus dexamethasone 8 mg after the induction of anesthesia and placebo 12 h later (Group 3, n = 30). A complete response, defined as no PONV in 48 h, occurred in 80% of patients in Group 1, 70% in Group 3, and 40% in Group 2 (P = 0.004 versus Groups 1 and 3). The incidences of side effects and other variables that could modify the incidence of PONV were similar among groups. In conclusion, ondansetron, in combination with droperidol or dexamethasone, is more effective than dexamethasone in combination with droperidol in women undergoing general anesthesia for major gynecological surgery with intrathecal morphine plus IV PCA with morphine for postoperative analgesia. IMPLICATIONS: The combination of ondansetron plus dexamethasone or droperidol was significantly better than the combination of dexamethasone plus droperidol in the prophylaxis of postoperative nausea and vomiting in women undergoing general anesthesia for major gynecological surgery, with intrathecal and IV morphine (patient-controlled analgesia) for management of postoperative pain.     

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.     

Efficacy, Dose-Response, and Safety of Ondansetron in Prevention of Postoperative Nausea and Vomiting: A Quantitative Systematic Review of Randomized Placebo-controlled Trials

Objective: The authors reviewed efficacy and safety data for ondansetron for preventing postoperative nausea and vomiting (PONV).

Methods: Systematically searched, randomized, controlled trials (obtained through MEDLINE, EMBASE, Biological Abstracts, manufacturer's database, manual searching of journals, and article reference lists) were analyzed. Relevant end points were prevention of early PONV (within 6 h after surgery) and late PONV (within 48 h) and adverse effects. Relative benefit and number-needed-to-treat were calculated. The number-needed-to-treat indicated how many patients had to be exposed to ondansetron to prevent PONV in one of them who would have vomited or been nauseated had he or she received placebo.

Results: Fifty-three trials were found that had data from 7,177 patients receiving 24 different ondansetron regimens and from 5,712 controls receiving placebo or no treatment. Average early and late PONV incidences without ondansetron were 40% and 60%, respectively. There was a dose response for oral and intravenous ondansetron. Best number-needed-to-treat to prevent PONV with the best documented regimens was between 5 and 6. This was achieved with an intravenous dose of 8 mg and an oral dose of 16 mg. Antivomiting efficacy was consistently better than antinausea efficacy. Efficacy in children was poorly documented. Ondansetron significantly increased the risk for elevated liver enzymes (number-needed-to-harm was 31) and headache (number-needed-to-harm was 36).     

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.     

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.     

Comparison of anti-emetic effects of ondansetron, metoclopromide or a combination of both in children undergoing surgery for strabismus

This prospective, randomized and double-blinded study was designed to evaluate the anti-emetic efficacy of a combination of ondansetron and metoclopramide in 100 ASA physical status I and II children of either sex and 1-15 years of age undergoing elective surgery for strabismus. A standardized anaesthetic technique and post-operative analgesia were used for all the children. Children were divided into four groups. They received saline, metoclopromide 250 micrograms kg-1, ondansetron 150 micrograms kg-1 or a combination of metoclopramide 150 micrograms kg-1 and ondansetron 100 micrograms kg-1 intravenously immediately after the insertion of an intravenous cannulae. There were no differences between the groups in their age, gender, weight, duration of surgery, number of muscles subjected to surgery or intravenous fluids received. In the first 24 post-operative hours, 18 (72%) patients in the placebo group, 15 (60%) patients in the metoclopramide group, 10 (40%) patients in the ondansetron group and 11 (44%) patients in the combination group had nausea or vomiting. The overall incidence of post-operative nausea and vomiting was significantly (P < 0.05) lower in the combination group and in the ondansetron group compared with the placebo group. Nine (36%) patients in both the placebo and the metoclopramide groups and one (4%) patient in the ondansetron group required rescue anti-emetic treatment. None of the patients in the combination group required rescue anti-emetic and this was significantly less (P < 0.01) when compared with the placebo and the metoclopramide groups. Recovery and sedation scores were comparable in all the four groups. A combination of metoclopramide 150 micrograms kg-1 and ondansetron 100 micrograms kg-1 administered prior to surgery was not found to be more effective than ondansetron 150 micrograms kg-1 alone for the prophylaxis of nausea and vomiting following surgical repair of strabismus in paediatric patients.     

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.     

Antiemetic prophylaxis for office-based surgery: are the 5-HT3 receptor antagonists beneficial?

BACKGROUND: Office-based surgery has become increasingly popular because of its cost-saving potential. However, the occurrence of postoperative nausea and vomiting (PONV) can delay patient discharge. Prophylaxis using a combination of antiemetic drugs has been suggested as an effective strategy for minimizing PONV. The authors designed this randomized, double-blinded, placebo-controlled study to assess the efficacy of ondansetron and dolasetron when administered in combination with droperidol and dexamethasone for routine antiemetic prophylaxis against PONV in the office-based surgery setting. METHODS: Following institutional review board approval, 135 consenting outpatients with American Society of Anesthesiologists physical status I-III who were undergoing superficial surgical procedures lasting 20-40 min were randomly assigned to one of three antiemetic treatment groups. Propofol was administered for induction of anesthesia, followed by 2-4% desflurane with 67% nitrous oxide in oxygen. Desflurane was subsequently adjusted to maintain a clinically adequate depth of anesthesia with an electroencephalographic Bispectral Index value between 50 and 60. All patients received 0.625 mg intravenous droperidol and 4 mg intravenous dexamethasone after induction of anesthesia. The study medication, containing normal saline (control), 12.5 mg intravenous dolasetron, or 4 mg intravenous ondansetron, was administered prior to the end of surgery. All patients received local anesthetics at the incisional site and 30 mg intravenous ketolorac to minimize postoperative pain. Recovery profiles, incidence of PONV, requirement for rescue antiemetic drugs, complete response rates, and patient satisfaction were assessed. RESULTS: The recovery times to patient orientation, oral intake, ambulation, and actual discharge did not differ among the three groups. The incidence of PONV, nausea scores, and requirement for rescue antiemetics were also similar in all three groups during the 24-h study period. In addition, the complete response rates to the prophylactic antiemetics (96-98%) and percentages of very satisfied patients (93-98%) were equally high in all three groups. However, the antiemetic drug acquisition costs were US $2.50, $15.50, and $18.50 in the control, dolasetron, and ondansetron groups, respectively. CONCLUSION: The addition of dolasetron (12.5 mg) or ondansetron (4 mg) failed to improve the antiemetic efficacy of droperidol (0.625 mg intravenous) and dexamethasone (4 mg intravenous) when they were used for routine prophylaxis in the office-based surgery setting.     

Ondansetron for the Prevention of Postoperative Nausea and Vomiting: Which is the Best Dosage for Aesthetic Plastic Surgery?

Background Ondansetron has been used widely in plastic surgery to prevent postoperative nausea and vomiting. A literature search showed controversial dosages of this drug, and because of its short half-life, its use only before anesthetic induction could have a limited effect. The purpose of this study was to assess the efficacy of intravenous (IV) ondansetron (4 mg) for aesthetic plastic surgery performed with the patient under general anesthesia and the prophylaxis of postoperative nausea and vomiting (PONV) in two situations: (a) only before anesthetic induction and (b) before anesthetic induction and immediately before extubation.Methods Of the 60 patients who had general anesthesia for aesthetic plastic surgery, 30 received 4 mg of IV ondansetron before anesthetic induction (control group) and 30 received 4 mg of IV ondansetron before anesthetic induction plus 4 mg IV immediately before extubation (experimental group). The PONV was recorded in the postanesthetic care unit and in the hospital room.Results The total occurrence of PONV (n = 60) was 6.7%. In the postanesthetic care unit, one patient in the experimental group (3.3%) manifested this symptom. In the hospital room, two patients in the control group (6.7%) and one patient in the experimental group (3.3%) manifested PONV.Conclusion According to the findings, there was no statistical difference between the groups. However, the dosage used in the control group was effective and less expensive.