A randomized, double-blind comparison of ondansetron versus placebo for prevention of nausea and vomiting after infratentorial craniotomy

Ondansetron was compared with placebo for nausea and vomiting prophylaxis after fentanyl/isoflurane/relaxant anesthesia and infratentorial craniotomy. Eight milligrams intravenous ondansetron or vehicle was administered at skin closure. Nausea, emesis, and antiemetic use were recorded at 0, 0.5, 1, 4, 8, 12, 24, and 48 hours. There were no significant intergroup differences for nausea incidence at any interval, but cumulatively the placebo group was 3.2 times more likely to develop nausea during the first 12 hours (P = .04). Nausea incidence was bimodal in both groups, peaking during the first 1 to 4 hours. A nadir occurred at 8 to 12 hours, but nausea increased during the next 36 hours. By 48 hours, approximately 40% of patients in both groups were still nauseated. Reduced vomiting frequency was seen with ondansetron at 4, 8, 12, and 24 hours (P < .05). Despite rescue antiemetics, emesis occurred in an irregular pattern with episodes still observed in 35% of placebo patients at 48 hours. For ondansetron, emesis was infrequent for the first 12 hours but then a persistent increase was observed (48 hours, 22%). The incidence of rescue antiemetic use was 65% for both groups. There was no effect of gender. Nausea and vomiting are frequent and protracted after infratentorial craniotomy. Administration of single-dose ondansetron (8 mg intravenously) at wound closure was partially effective in reducing acute nausea and vomiting but had little delayed benefit. Scheduled prophylactic administration of antiemetic therapy during the first 48 hours after infratentorial craniotomy should be evaluated for efficacy and safety.     

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.     

Haloperidol vs. ondansetron for the prevention of postoperative nausea and vomiting following gynaecological surgery

BACKGROUND AND OBJECTIVE: Ondansetron is widely used for the prophylaxis of postoperative nausea and vomiting, while haloperidol is an antiemetic that lacks recent data on efficacy and adverse effects. METHODS: In this prospective, randomized, double-blinded study involving 93 females undergoing gynaecological procedures under general anaesthesia, we compared the efficacy and adverse effects of prophylactic haloperidol 1 mg intravenous and ondansetron 4 mg intravenous vs. placebo. RESULTS: During the overall observation period (0-24 h), in the haloperidol, ondansetron and placebo groups respectively, the incidence of nausea and/or vomiting was 40.7% (11/27), 48.2% (13/27) and 55.5% (15/27), and the need of rescue antiemetics was 22.2% (6/27), 44.4% (12/27) and 40.7% (11/27), with P values >0.05 among the three groups. During the early observation period (0-2 h), in the haloperidol, ondansetron and placebo groups respectively, the incidence of nausea and/or vomiting was 13.7% (4/29), 26.6% (8/30) and 43% (13/30), and the need for rescue antiemetics was 6.8% (2/29), 26.6% (8/30) and 36.6% (11/30). Between haloperidol and placebo groups, the P value was 0.04 for nausea and/or vomiting, and was 0.01 for rescue antiemetics, in addition to lower nausea scores (P = 0.03). During the late observation period (2-24 h), no significant difference was shown among the three groups. CONCLUSION: The prophylactic administration of 1 mg intravenous haloperidol or 4 mg ondansetron, in female patients undergoing gynaecological surgery, did not improve the overall incidence of nausea and/or vomiting vs. placebo. However, haloperidol 1 mg proved to be an effective antiemetic in the early observation period without significant adverse effects.     

Antiemetic efficacy of ondansetron after outpatient laparoscopy.

The safety and efficacy of ondansetron were evaluated for the treatment of postoperative nausea and vomiting after laparoscopic surgical procedures. Seventy-one healthy, consenting outpatients were randomly assigned to one of two treatment groups according to a double-blind, placebo-controlled protocol. A standardized anesthetic technique consisting of alfentanil-thiopental-succinylcholine for induction and alfentanil-nitrous oxide-succinylcholine for maintenance of anesthesia was used. Patients in whom postoperative nausea and/or vomiting developed and persisted for greater than or equal to 10 min received equivolemic intravenous injections of either ondansetron (8 mg) or saline (placebo) over a 2-5 min period. Ondansetron significantly decreased the posttreatment nausea scores (vs placebo) without increasing sedation or producing changes in cardiorespiratory parameters. In the placebo-treated group, 92% of the patients experienced subsequent episodes of vomiting in the postanesthesia care unit compared with 51% of the patients in the ondansetron group. Finally, only 43% of the ondansetron-treated patients required a "rescue" antiemetic compared with 86% in the placebo group. Thus, ondansetron (8 mg IV) was associated with a decreased incidence of nausea and vomiting after outpatient laparoscopic procedures.     

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.     

Prophylacticiv ondansetron reduces nausea, vomiting and pruritus following epidural morphine for postoperative pain control

PURPOSE: To evaluate the prophylactic effect of ondansetron on nausea and vomiting following epidural morphine for postoperative pain control. METHODS: Seventy women (n = 35 in each group) undergoing abdominal total hysterectomy under epidural anesthesia were enrolled in this randomized, double-blinded, and placebo-controlled study. At the end of surgery, all patients received epidural morphine 3 mg for postoperative pain relief. Before morphine injection, the ondansetron group received iv ondansetron 4 mg, whereas the placebo group received iv saline. RESULTS: Patients in the ondansetron group reported a lower frequency of total postoperative nausea and vomiting (22%) and lower frequency of rescue antiemetic request (12%) than those in the placebo group (52% and 39%, respectively; P < 0.05). In addition, ondansetron was associated with a reduced incidence of pruritus following epidural morphine (28% vs 58%; P < 0.05). CONCLUSION: We conclude that iv ondansetron 4 mg is effective in the prevention of nausea, vomiting, and pruritus following epidural morphine for postoperative pain control.     

Ondansetron, orally disintegrating tablets versus intravenous injection for prevention of intrathecal morphine-induced nausea, vomiting, and pruritus in young males

In this study we compared the efficacy of orally disintegrating tablets (ODT) and IV ondansetron for preventing spinal morphine-induced pruritus and postoperative nausea and vomiting (PONV) in healthy young male patients. Patients who received bupivacaine with 0.20 mg morphine for spinal anesthesia were randomly assigned to the ODT group (ODT ondansetron 8 mg, n = 50), the IV group (4 mg ondansetron IV, n = 50), or the placebo group (n = 50). Each individual was assessed for pruritus, postoperative nausea and vomiting, and pain at 0, 2, 6, 12, 18, and 24 h after surgery using three distinct visual analog scales. The frequencies of postoperative nausea and vomiting and frequencies of requirement for rescue antiemetic and antipruritic were recorded. There were no significant differences among the three groups with respect to incidence or severity of PONV or postoperative pain visual analog scale scores. The incidences of pruritus in the ODT (56%) and IV (66%) groups were significantly different from that in the placebo group (86%) (P < 0.02 for both). Only the ODT group had significantly lower mean pruritus visual analog scale scores at 0, 2, 6, and 12 h postsurgery than the placebo group (P < 0.023 for all). The frequency of requirement for rescue antipruritic was significantly less in the ODT group than the placebo group (P = 0.013). Both ODT ondansetron 8 mg and IV ondansetron 4 mg are more effective than placebo for preventing spinal morphine-induced pruritus, but neither form of this agent reduces spinal morphine-induced postoperative nausea and vomiting in this patient group.     

A randomized, double-blinded comparison of ondansetron, droperidol, and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy

Nausea or vomiting occurs frequently after craniotomy. Because of the need for frequent postoperative neurological assessment, an effective antiemetic with minimal sedative side effects is needed. Therefore, we compared ondansetron to droperidol in a randomized, double-blinded, placebo-controlled study. A total of 60 adults requiring elective supratentorial craniotomy received standardized IV anesthesia with 4 mg of ondansetron, 0.625 mg of droperidol, or placebo at skin closure. The incidence of postoperative nausea, emesis, pain and sedation scores, and rescue antiemetic use were recorded at 0, 0.5, 1, 4, 8, 12, 24, and 48 h. All groups were demographically similar. Differences existed for cumulative 8, 12, and 24 h incidences of nausea (24 h, P = 0.03) and emesis (24 h, P = 0.04). Within 4 h, when maximal effect could be expected from treatment, 20% of the ondansetron group, 25% of the droperidol group and 50% of the placebo group received rescue antiemetic (P = 0.12). No differences in pain (P = 0.82) or sedation (P = 0.74) scores were detected. Both ondansetron and droperidol prevent nausea; however, only droperidol reduces emesis after supratentorial craniotomy. The dose of droperidol used was not more sedating than ondansetron. Sustained reduction in nausea and emesis over 24 h indicates a preemptive benefit of prophylactic antiemetic in this surgical population. Implications: Nausea and vomiting after brain surgery are particularly troubling, because effective treatment may cause sedation, making postoperative neurological assessment difficult. Our study shows that both ondansetron and droperidol are effective in reducing nausea, and that droperidol is particularly effective in reducing vomiting. Neither drug caused more sedation than placebo.     

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.     

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.     

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.     

Comparison of oral dolasetron and ondansetron in the prophylaxis of postoperative nausea and vomiting in children

BACKGROUND AND OBJECTIVE: In a randomized, placebo-controlled, double-blind trial, we compared the efficacy of oral dolasetron and ondansetron in preventing postoperative nausea and vomiting in children after various surgical operations. METHODS: Children were assigned randomly to one of three groups (each contained 50 children) to receive dolasetron 1.8 mg kg(-1) or ondansetron 0.15 mg kg(-1) orally, or a placebo. All children received methylene blue capsules (10 mg) orally as an indicator before the induction of anaesthesia. Postoperatively, contamination of the mouth and the endotracheal tube by methylene blue was recorded, and postoperative nausea and vomiting was recorded for 0-1, 1-24 and 0-24 h. Metoclopramide (0.1 mg kg(-1)) intravenously was used as the rescue antiemetic. RESULTS: In the 0-1 h period after operation, there were no differences between the groups. In the 1-24 h period, dolasetron was significantly better than placebo (nausea 8 versus 24%; vomiting 4 versus 20%; total nausea and vomiting scores 16 versus 48%). Over the 0-24 h period, both dolasetron and ondansetron were significantly better than placebo (nausea 16 versus 26 versus 40%), vomiting (8 versus 16 versus 30%), and total nausea and vomiting scores (32 versus 48 versus 78%). There were no significant differences between dolasetron and ondansetron. There was no important methylene blue contamination, and little use of rescue metoclopramide. There were no important adverse events. CONCLUSIONS: Prophylactic oral dolasetron and ondansetron were effective in reducing postoperative nausea and vomiting in children.     

Prevention of postoperative nausea and vomiting using ondansetron, a new, selective, 5-HT3 receptor antagonist.

The effect of ondansetron, a 5-HT3 antagonist, in preventing postoperative nausea and vomiting was investigated in a randomized, double-blind, placebo-controlled study of 84 patients undergoing gynecologic operation and receiving the same general anesthetic. The patients received premedication with either 16 mg oral ondansetron, or a matching placebo. The same medication was given postoperatively 8 h after the first dose. During the first hour after recovery from anesthesia, the frequencies of nausea and vomiting were 52% and 40%, respectively, in patients given placebos. In the ondansetron group nausea and vomiting developed in 17% and 12%, respectively, values significantly different from those with placebos (P less than 0.005). Similar differences were observed throughout the entire 24-h period after recovery, the incidence of nausea and vomiting being 67% and 60%, respectively, in the placebo group and 29% and 26% in the ondansetron treatment group. Ondansetron appears to be a promising antiemetic for the prevention of postoperative nausea and vomiting.     

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。     

Comparative efficacy of acustimulation (ReliefBand) versus ondansetron (Zofran) in combination with droperidol for preventing nausea and vomiting

BACKGROUND: Antiemetic drugs are costly, are associated with variable efficacy, and can produce unwanted side effects when used for prophylaxis against postoperative nausea and vomiting. This clinical study was designed to compare the efficacy of transcutaneous electrical acupoint stimulation using a ReliefBand to ondansetron (Zofran) when utilized alone or in combination for preventing postoperative nausea and vomiting after plastic surgery. METHODS: A single-center, randomized, double-blind, placebo- and sham-controlled study design was conducted to compare three prophylactic antiemetic treatment regimens in 120 outpatients undergoing plastic surgery procedures with routine low-dose droperidol prophylaxis: (1) ondansetron (n = 40), 4 mg intravenous ondansetron and a sham ReliefBand; (2) acustimulation (n = 40), 2 ml intravenous saline and an active ReliefBand; and (3) combination (n = 40), 4 mg intravenous ondansetron and an active ReliefBand. The incidences of postoperative nausea and vomiting, as well as the need for "rescue" antiemetics, were determined at specific time intervals for up to 72 h after surgery. The outcome variables assessed included recovery times, quality of recovery score, time to resumption of normal diet, and patient satisfaction with the prophylactic antiemetic therapy. RESULTS: Use of the ReliefBand in combination with ondansetron significantly reduced nausea (20 vs. 50%), vomiting (0 vs. 20%), and the need for rescue antiemetics (10 vs. 37%) compared with ondansetron alone at 24 h after surgery. Furthermore, the ability to resume a normal diet (74 vs. 35%) within 24 h after surgery was significantly improved when the ReliefBand was used to supplement ondansetron (vs. ondansetron alone). Finally, the quality of recovery (90 +/- 10 vs.70 +/- 20) and patient satisfaction (94 +/- 10 vs. 75 +/- 22) scores were significantly higher in the combination group the ondansetron group. There were no significant differences between the ReliefBand and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis. CONCLUSIONS: The ReliefBand compared favorably to ondansetron (4 mg intravenously) when used for prophylaxis against postoperative nausea and vomiting. Furthermore, the acustimulation device enhanced the antiemetic efficacy of ondansetron after plastic surgery.     

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.     

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.     

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.     

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.     

Comparing the efficacy of prophylactic metoclopramide, ondansetron, and placebo in cesarean section patients given epidural anesthesia

STUDY OBJECTIVE: To compare the relative efficacy of prophylactic metoclopramide, ondansetron, and placebo in nonemergent cesarean section patients given epidural anesthesia intraoperatively and for the first 24-hour period after delivery. DESIGN: Randomized, double blind, placebo-controlled study. SETTING: Inpatient obstetric unit at a university hospital center. PATIENTS: 164 nonemergent cesarean section patients given epidural anesthesia. INTERVENTION: At time of umbilical cord clamp, patients received intravenously (IV) either 4 mg ondansetron (Group O) or 10 mg metoclopramide (Group M) or 10 mL normal saline (Group P). MEASUREMENTS AND MAIN RESULTS: Episodes and severity of nausea and vomiting, rescue antiemetic requirement, patient satisfaction, and side effects were recorded. The frequency of intraoperative nausea were 24%, 43%, and 57% for Group O, Group M, and Group P, respectively (p < 0.03). The frequency of nausea for the 24-hour study period were 26%, 51% and 71% for Groups O, M, and P respectively (p < 0.03). The frequency of intraoperative and postoperative vomiting were similar between Group O and Group M, but significantly higher in Group P (p < 0.05). Overall patient satisfaction was highest in Group O compared with Groups P and M (p < 0.05). Maximum analog sedation score was higher in Group M compared to Groups O and P (p < 0.05). CONCLUSIONS: In cesarean section patients given epidural anesthesia, prophylactic ondansetron, 4 mg IV, is more efficacious and has a higher patient satisfaction than that with metoclopramide, 10 mg IV, or placebo in preventing nausea and achieving complete responses during intraoperative period and the first 24-hour postdelivery period. However, there is no difference between ondansetron and metoclopramide in reducing frequency of vomiting. Prophylactic ondansetron 4 mg IV is more effective in preventing nausea than vomiting.