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.     

A comparison of dexamethasone,ondansetron, and dexamethasone plus ondansetron as prophylactic antiemetic and antipruritic therapy in patients receiving intrathecal morphine for major orthopedic surgery

In a prospective, double-blinded, randomized trial, we evaluated the efficacy of IV (a) dexamethasone 8 mg, (b) ondansetron 8 mg, and (c) dexamethasone 8 mg plus ondansetron 4 mg for the prevention of postoperative nausea, vomiting (PONV), and pruritus in 130 (ASA physical status I to III) patients undergoing elective major orthopedic surgery after spinal anesthesia with hyperbaric 0.5% bupivacaine and intrathecal morphine. After spinal anesthesia, patients were randomized to one of three groups. Failure of PONV prophylaxis in the 24-h postoperative period occurred more frequently in patients who received dexamethasone alone (29 of 40; 73%) compared with those who received either ondansetron alone (23 of 47; 49%) (P = 0.02) or dexamethasone plus ondansetron together (19 of 43; 44%)(P = 0.01). There was no difference in the incidence of failure of prophylaxis of pruritus (70%, 72%, and 70% in dexamethasone 8 mg, ondansetron 8 mg, and dexamethasone 8 mg plus ondansetron 4 mg, respectively) (P > 0.1) in the 24-h postoperative period. We conclude that the administration of dexamethasone 8 mg with ondansetron 4 mg has no added benefit compared with ondansetron 8 mg alone in the prophylaxis of PONV and pruritus. IMPLICATIONS: Postoperative nausea and vomiting (PONV) and pruritus are common side effects after spinal opioid administration. In this study, dexamethasone 8 mg plus ondansetron 4 mg was as effective as ondansetron 8 mg. The administration of dexamethasone alone was associated with a frequent incidence of PONV, demonstrating a lack of efficacy. This has important cost implications.     

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.     

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.     

Prophylactic intravenous ondansetron and dolasetron in intrathecal morphine-induced pruritus: a randomized, double-blinded, placebo-controlled study

Pruritus is the most common side effect of intrathecal morphine for postoperative pain relief. Activation of central 5-hydroxytryptamine subtype 3 (5-HT3) receptors is one of its possible mechanisms. The role of 5-HT3 antagonists in the prevention of pruritus has not been clearly established. In a prospective, randomized, double-blind, placebo-controlled study, we evaluated the efficacy of prophylactic administration of ondansetron and dolasetron for the prevention of intrathecal morphine-induced pruritus. The patients were randomized into 3 groups to receive either 4 mg ondansetron IV (group O, n = 35), 12.5 mg dolasetron IV (group D, n = 35) or 5 mL placebo (group P, n = 35) 30 min before administration of spinal anesthesia with 10 to 17.5 mg of 0.5% hyperbaric bupivacaine and 0.25 mg of morphine for urologic, orthopedic, or vascular surgery. Patients were evaluated for incidence and severity of pruritus at arrival to the postanesthesia care unit and at 2, 4, 8, and 24 h postoperatively. The incidence and severity of pruritus was significantly less frequent in the ondansetron and dolasetron groups compared with placebo (34%, 20%, and 66% respectively, P < 0.01). Patients who received 5-HT3 antagonist reported significantly less total severity of pruritus compared with placebo during the first 8 h and the severe pruritus was observed only in patients within P group (P group: 4 of 35; 11%, O or D group: 0 of 35; 0%, P < 0.05). We conclude that the prophylactic use of ondansetron and dolasetron helps to reduce the incidence and severity of intrathecal morphine-induced pruritus.     

Tropisetron vs ondansetron for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy: a randomized double-blind,placebo-controlled study

Background: Postoperative nausea and vomiting are observed in increased frequency after laparoscopic surgery. This study was performed in order to compare the efficacy of two 5-hydroxytryptamine-3 (5-HT3) receptor antagonists, ondansetron and tropisetron, in preventing postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy. Methods: Using a randomized, double-blind study design, 87 ASA I and II patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive 4 mg ondansetron (Group A, n = 29), 5 mg tropisetron (Group B, n = 31), or placebo (Group C, n = 27) intravenously (IV) before induction of anesthesia. The end points evaluated were frequency of nausea, nausea intensity rated on a scale from 1 (mild) to 5 (most severe), frequency of vomiting, and need for rescue antiemetics. These parameters were measured immediately after surgery (0 h), at 3 h, 6 h, and 12 h postoperatively. Results: The frequency of nausea was significantly higher in group A (31.2%) compared to group B (14%) at 12 h postoperatively (p <0.01). However, patients of group A had significantly lower nausea scores at 3 h postoperatively compared to group B. Postoperative vomiting occurred in 13.8% of patients in group A and 9.6% of patients in group B throughout the whole study period (p = n.s.). The need for rescue antiemetics was similar between groups A and B. Both groups were superior to placebo concerning all studied parameters. Conclusion: Our results show that ondansetron may be more effective in controlling nausea intensity during the first 3 h after laparoscopic cholecystectomy, while tropisetron has a longer-acting activity, with a major impact on nausea frequency at 12 h postoperatively.     

The efficacy of postoperative ondansetron (Zofran) orally disintegrating tablets for preventing nausea and vomiting after acoustic neuroma surgery

Postoperative nausea and vomiting is a frequent complication of craniotomy. We evaluated the ability of intraoperative IV ondansetron followed by postoperative ondansetron in an orally disintegrating tablet formulation to reduce the frequency and severity of postoperative nausea and vomiting in a prospective, randomized, placebo-controlled double-blind trial of 60 patients undergoing acoustic neuroma resection. Each patient received intraoperative ondansetron (4 mg IV) or placebo 30 min before case end. Postoperatively, patients received ondansetron in an orally disintegrating tablet formulation (8 mg BID) or placebo twice a day for up to 72 h. Metoclopramide was available as rescue therapy for both groups. Severity of nausea (as measured on a 10-cm visual scale), number of emetic episodes, and requirement for rescue therapy were recorded. In the immediate postoperative period, nausea severity was less in patients treated with ondansetron than placebo (3.3 +/- 4.1 versus 7.3 +/- 4.2; P < 0.001) and fewer patients experienced vomiting (3 of 28 versus 11 of 32; chi2 P < 0.01). More patients required some form of rescue treatment in the placebo group on the first postoperative day (26 of 32 versus 16 of 28; chi2 P < 0.01). We conclude that after acoustic neuroma surgery IV ondansetron treatment prevents immediate postoperative nausea and vomiting. Postoperative treatment with ondansetron in an orally disintegrating tablet formulation was associated with less frequent rescue therapy as compared with placebo on the first postoperative day.     

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。     

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.     

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.     

Small-dose droperidol effectively reduces nausea in a general surgical adult patient population

In this prospective, randomized, placebo-controlled study, we (1) determined whether 0.625 mg of IV droperidol given 30 min before emergence from general anesthesia reduces the incidence of immediate and delayed postoperative nausea and vomiting (PONV) in a general surgical adult patient population, and (2) compared the efficacy of droperidol, ondansetron, and promethazine for the rescue treatment of PONV. One hundred fifty adult patients receiving general anesthesia for >2 h received either droperidol (0.625 mg IV) or a placebo before emergence. Patients requiring treatment for PONV in the postanesthesia care unit were randomized to receive either droperidol (0.625 mg IV), ondansetron (4 mg IV), or promethazine (12. 5 mg IV). Droperidol effectively prevented PONV (6.8% in droperidol-treated patients versus 40.8% in placebo-treated patients, P: < 0.001). Droperidol, ondansetron, and promethazine were equally effective in treating established PONV, without significant differences in side effects or time to postanesthesia care unit discharge. Implications: Droperidol 0.625 mg IV before emergence from general anesthesia effectively reduces postoperative nausea and vomiting (PONV) in the general surgical population. Our randomized, double-blinded, placebo-controlled study demonstrated a reduction in PONV from 41% to 7%. Droperidol is a safe and inexpensive alternative to ondansetron. Droperidol, ondansetron, and promethazine are also equally effective in treating PONV in the postanesthesia care unit.     

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 patients undergoing total abdominal hysterectomy under spinal anaesthesia: a randomized study of ondansetron prophylaxis

BACKGROUND AND OBJECTIVE: Patients undergoing total abdominal hysterectomy under general anaesthesia have a high risk of developing postoperative nausea and vomiting (PONV). The aim of this study was to evaluate the incidence of PONV in patients undergoing total abdominal hysterectomy under spinal anaesthesia with intravenous patient-controlled analgesia (PCA) using morphine and to compare its incidence with and without antiemetic prophylaxis. METHODS: Thirty-four patients undergoing total abdominal hysterectomy under spinal anaesthesia with i.v. PCA morphine postoperatively were divided into two groups. The first (n = 17) received ondansetron prophylaxis near the end of surgery while the second (n = 17) received no prophylaxis. Morphine consumption, emetic episodes (on a 3-point scale), patient satisfaction (visual analogue score), sedation and pruritus were evaluated 2, 4, 6, 9, 12, 18 and 24h postoperatively. RESULTS: Patient characteristics, postoperative morphine consumption (43.3 +/- 7.6 vs. 40.3 +/- 12.3 mg) and peristaltic recovery time (16.9 +/- 5 vs. 18.4 +/- 5.2 h) were similar in both groups. Overall nausea and vomiting were significantly lower in the ondansetron prophylaxis group than in the group without prophylaxis (52.9% vs. 88.2%, P < 0.05). Though nausea alone was higher in the prophylaxis group (41.2% vs. 29.4%), nausea with vomiting was significantly lower in the prophylaxis group (11.8% vs. 58.8%, P < 0.01). Patients' satisfaction scores were higher in the ondansetron group at all times and the difference was significant (P < 0.05) 4 h postoperatively. CONCLUSIONS: The incidence of PONV in patients undergoing total abdominal hysterectomy under spinal anaesthesia with i.v. PCA morphine is very high (88.2%). Antiemetic prophylaxis with ondansetron is highly recommended in this patients group resulting in a lower incidence of nausea and vomiting, and significantly improves patient' satisfaction and life quality in the early postoperative period.     

Combination of ondansetron and dexamethasone in the prophylaxis of postoperative nausea and vomiting

We studied 100 ASA I-II females undergoing general anaesthesia for major gynaecological surgery, in a prospective, double-blind, placebo- controlled, randomized study. Patients received one of four regimens for the prevention of postoperative nausea and vomiting (PONV): ondansetron 4 mg (n = 25), dexamethasone 8 mg (n = 25), ondansetron with dexamethasone (4 mg and 8 mg, respectively, n = 25) or placebo (saline, n = 25) There were no differences in background factors or factors related to operation and anaesthesia, morphine consumption, pain or side effects between groups. The incidence of nausea and emetic episodes in the ondansetron with dexamethasone group was lower than in the placebo (P < 0.01), ondansetron (P < 0.05) and dexamethasone (P = 0.057) groups. There were no differences between ondansetron and dexamethasone, and both were more effective than placebo (P < 0.05 and P < 0.01, respectively). Dexamethasone appeared to be preferable in preventing nausea than emetic episodes. Fewer patients in the ondansetron with dexamethasone group needed antimetic rescue (P < 0.01 vs placebo and P < 0.05 vs ondansetron). We conclude that prophylactic administration of combined ondansetron and dexamethasone is effective in preventing PONV.      

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.     

Prophylactic ondansetron is effective in the treatment of nausea and vomiting but not on pruritus after cesarean delivery with intrathecal sufentanil-morphine

STUDY OBJECTIVES: To assess the safety and efficacy of ondansetron for prevention of pruritus, nausea and vomiting after cesarean delivery with intrathecal sufentanil-morphine. DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Referral center, institutional practice. PATIENTS: 100 nonbreastfeeding women undergoing elective cesarean delivery with sufentanil-morphine-bupivacaine anesthesia. INTERVENTIONS: After the umbilical cord was clamped, patients in Group 1 received ondansetron 8 mg intravenously (IV) and patients in Group 2 received placebo. MEASUREMENTS: Frequency and severity of postoperative (24-hour) pruritus, nausea and vomiting, surgical pain, and side effects related to ondansetron were recorded. MAIN RESULTS: In the ondansetron group, 38 patients had pruritus (16 mild and 22 severe) and 9 patients had nausea and vomiting (5 mild and 4 severe). In the placebo group, 41 patients had pruritus (21 mild and 20 severe) and 29 patients had nausea and vomiting (9 mild and 15 severe). The frequency and severity of the nausea and vomiting episodes were significantly reduced in the ondansetron group. Pain scores were comparable between groups. No side effects related to ondansetron were reported. CONCLUSIONS: Prophylactic IV ondansetron 8 mg is safe and effective in reducing the frequency and the severity of nausea and vomiting, but not pruritus, following cesarean delivery with intrathecal sufentanil-morphine.     

Efficacy of prophylactic droperidol, ondansetron or both in the prevention of postoperative nausea and vomiting in major gynaecological surgery. A prospective, randomized, double-blind clinical trial

We conducted a prospective, randomized, double-blind clinical trial comparing droperidol 1.25 mg intravenously (i.v.) (group 1, n = 30), ondansetron 4 mg i.v. (group 2, n = 30), or both (group 3, n = 30) in the prevention of postoperative nausea and vomiting (PONV) in the first 24 h following major gynaecological procedures under combined general and epidural anaesthesia. PONV was analysed by a linear nausea/vomiting score, incidence of nausea and vomiting, and the need for antiemetic rescue. Our results showed a similar incidence of nausea and vomiting in all groups (G1 33%, G2 40%, G3 43%). However, when comparisons were made according to the time of assessment, combination therapy resulted in significantly lower PONV than droperidol in the first hour (0% vs. 13%, P < 0.05) and second hour (0% vs. 13%, P < 0.05), and than ondansetron on the first hour (0% vs. 13%, P < 0.05). A trend persisted up to the fourth hour but was not statistically significant in either group. In conclusion, droperidol and ondansetron are effective agents in the prevention of PONV, and their combination seems to provide slightly better results than either drug alone.     

Dolasetron versus ondansetron for the treatment of postoperative nausea and vomiting

The management of postoperative nausea and vomiting (PONV) remains a persistent problem. Despite the use of prophylactic antiemetics, breakthrough nausea and vomiting still frequently occur. There have been no published studies comparing dolasetron and ondansetron for the treatment of PONV. This was a prospective, randomized, double-blind, active-controlled study in adult outpatient surgery patients. We screened 559 consecutive adult surgery patients, with 92 patients randomized to either ondansetron or dolasetron. The objectives of the study were 1) to determine whether treatment of PONV with ondansetron 4 mg IV or dolasetron 12.5 mg IV would result in better outcomes in patients undergoing day surgery and 2) to compare the cost of drugs used for treating PONV. Thirty-three (70%) of 47 patients given ondansetron required rescue medication, compared with 18 (40%) of 45 patients given dolasetron (P < 0.004). Dolasetron was approximately 40% less expensive than ondansetron, and the costs of the study drug plus rescue antiemetics were 30% less in the dolasetron group than in the ondansetron group. Dolasetron provided greater efficacy for antiemetic treatment because of the need for less rescue therapy. Because of the decreased use of rescue antiemetics and acquisition cost at our hospital, costs in the dolasetron group were less than costs in the ondansetron group.     

Nalbuphine versus ondansetron for prevention of intrathecal morphine-induced pruritus after cesarean delivery

In this prospective, randomized, double-blinded study, we compared the prophylactic efficacy of nalbuphine and ondansetron for the prevention of intrathecal morphine-induced pruritus after cesarean delivery. Two-hundred-forty parturients were randomly allocated into four groups. The N-4 group, O-4 group, O-8 group, and placebo group received IV 4 mg of nalbuphine, 4 mg of ondansetron, 8 mg of ondansetron, and 4 mL of normal saline, respectively, immediately after the baby was delivered. In the postanesthesia care unit, we found that the severity of pruritus score in the four groups was significantly different (P < 0.001). The prophylactic success rate for pruritus of the N-4, O-4, O-8, and placebo groups was 20%, 13%, 12%, and 6%, respectively (P < 0.001). The pruritus score between N-4 and placebo and O-4 and placebo was significantly different (P < 0.001 and P = 0.006, respectively). Treatment for pruritus was requested by patients in 25%, 47%, 51%, and 72% of patients in the N-4, O-4, O-8, and placebo groups, respectively (P < 0.001). There were no differences among groups in nausea/vomiting score, pain score, sedation score, or shivering score at 4, 8, and 24 h after surgery. Nalbuphine and ondansetron are more effective than placebo for the prevention of intrathecal morphine-induced pruritus after cesarean delivery. IMPLICATIONS: Nalbuphine and ondansetron are more effective than placebo for the prevention of intrathecal morphine-induced pruritus after cesarean delivery.     

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.