Substance P (Neurokinin-1) Antagonist Prevents Postoperative Vomiting after Abdominal Hysterectomy Procedures

Background: The safety and antiemetic efficacy of CP-122,721, a novel neurokinin-1 antagonist, was evaluated when administered alone or in combination with ondansetron.

Methods: Using a randomized, double-blind, placebo-controlled study design, CP-122,721 was initially compared with placebo and subsequently to ondansetron alone and in combination for prophylaxis against postoperative nausea and vomiting in 243 women undergoing abdominal hysterectomy. In the dose-ranging studies (n = 86), patients received either CP-122,721 100 mg (vs. placebo) or 200 mg (vs. placebo) orally 60-90 min before induction of anesthesia. In the interaction study (n = 157), patients received CP-122,721 200 mg or placebo 60-90 min before induction of anesthesia, and ondansetron 4 mg or saline 2 ml intravenously 15-30 min before the end of surgery. Patients assessed their level of nausea and pain on arrival in the postanesthesia care unit and at 0.5-, 1-, 1.5-, 2-, 4-, 8-, 12-, and 24-h intervals postoperatively. Emetic episodes, need for rescue antiemetic-antinausea medication, postoperative complications, and patient satisfaction were recorded.

Results: In the initial dose-ranging study, only 10% of the patients experienced emesis within the first 8 h after surgery with CP-122,721 200 mg compared with 50% in the placebo group. CP-122,721 200 mg also decreased the need for rescue medication (25%vs. 48%). CP-122,721 100 mg was less effective than 200 mg in decreasing the incidence of repeated episodes of emesis. In the interaction study, 6% of the patients receiving CP-122,721 200 mg orally experienced emesis less than 2 h after surgery compared with 17% with ondansetron alone. With combined therapy, only 2% experienced emesis. In addition, the median times for 75% of patients to remain free from postoperative nausea and vomiting were 82, 75, and 362 min in the ondansetron, CP-122,721, and combination groups, respectively.     

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.     

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.     

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.     

Intravenous Ondansetron in Established Postoperative Emesis in Children

Background: In pediatric postsurgical patients, postoperative vomiting is a common occurrence that can delay recovery and result in unplanned hospital admissions after outpatient surgery. This randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of ondansetron in the control of established postoperative emesis in outpatients aged 2-12 yr.

Methods: Screened for the study were 2,720 ASA physical status 1-3 children undergoing outpatient surgery during general anesthesia, which included nitrous oxide. Children experiencing two emetic episodes within 2 h of discontinuation of nitrous oxide were given intravenous ondansetron (n = 192; 0.1 mg/kg for children weighing less or equal to 40 kg; 4 mg for children weighing > 40 kg) or placebo (n = 183).

Results: The proportion of children with no emetic episodes and no use of rescue medication was significantly greater (P < 0.001) in the ondansetron group compared with placebo for both 2- and 24-h periods after study drug administration (78% of the ondansetron group and 34% of the placebo group for 2 h; 53% of the ondansetron group and 17% of the placebo group for 24 h). Among patients with at least one emetic episode or with rescue medication use, the median time to onset of emesis or rescue was 127 min in the ondansetron group compared with 58 min in the placebo group (P < 0.001). The median time from study drug administration until discharge was significantly shorter (P < 0.01) in the ondansetron group (153 min, range 44-593 min) compared with the placebo group (173 min, range 82-622 min). The incidence of potentially drug-related adverse events was similar in the ondansetron (3% of patients) and the placebo (4% of patients) groups.     

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.     

A randomized controlled trial of the antiemetic effect of three doses of ondansetron after strabismus surgery in children

METHODS: One hundred and thirty-one healthy children, aged 31-152 months, undergoing strabismus surgery under general anaesthesia, were randomly allocated to one of four groups: group A received 0.04 mg.kg-1 ( identical with 1 mg.m-2) of ondansetron, group B 0.1 mg.kg-1 ( identical with 2.5 mg.m-2), group C 0.2 mg.kg-1 ( identical with 5 mg.m-2) and group D placebo, given intravenously following induction of anaesthesia. Morphine 0.15 mg.kg-1 was given intravenously, intraoperatively, to provide postoperative analgesia. Hourly records of emetic episodes were made for 24 h. RESULTS: A considerably higher proportion of children suffered emesis in the placebo group compared to the active treatment groups taken together, during the first 8 h of postoperative care (76% vs. 45%, P=0.002). During the first 8 h, only 25% of those in treatment group C suffered emesis, the number-needed-to-treat was 3. There was a statistically significant decrease in the chance of vomiting with increasing dose of ondansetron (P=0.03). By 24 h, the difference in the rate of emesis was less marked but still statistically significant (90% vs. 69%, P=0.03). CONCLUSION: Overall, children given ondansetron had less than one-half the risk of vomiting compared to those given placebo (hazard ratio 0.46, 95% confidence interval 0.29-0.74). The mean number of emetic episodes declined from 2.73 in the placebo group to 1.92 in treatment group C. There was no difference in the incidence of side-effects between groups.     

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.     

Ondansetron versus placebo for prophylaxis of nausea and vomiting in patients undergoing ambulatory laparoscopic cholecystectomy

BACKGROUND: Postoperative nausea and vomiting is a common problem in patients undergoing laparoscopic cholecystectomy (LC). The purpose of this study was to evaluate the efficacy of ondansetron given at the induction of anesthesia in patients scheduled for ambulatory LC. METHODS: A total of 84 patients undergoing ambulatory LC were enrolled in a randomized, prospective, double-blinded study in which the subjects received either placebo or 4 mg ondansetron intravenously at induction of anesthesia. A nausea scoring system was employed utilizing a 5-point linear scale, with 1 point given for no nausea and a maximum of 5 points for an episode of emesis. Each patient received a total of four scores postoperatively. RESULTS: The patients receiving placebo had significantly more episodes of nausea (53 versus 32; P <0.009) and emesis (11 versus 2; P <0.02), higher mean total nausea scores (7.2 versus 5.4; P <0.006), and need for additional postoperative antiemetics (23 versus 14; P <0.05) than those receiving ondansetron. CONCLUSIONS: In patients undergoing ambulatory laparoscopic cholecystectomy, ondansetron at induction was highly effective in decreasing postoperative nausea and vomiting and should become the standard.     

A double-blind comparison of intravenous ondansetron and placebo for preventing postoperative emesis in 1- to 24-month-old pediatric patients after surgery under general anesthesia

We assessed the efficacy and safety of ondansetron (0.1 mg/kg IV) prophylactically administered before surgery for prevention of postoperative vomiting (POV) in a double-blind, placebo-controlled study of 670 pediatric patients, 1- to 24-mo-old, undergoing elective surgery under general anesthesia. The study enrolled 335 children in each treatment group (ondansetron versus placebo). Significantly fewer children treated with ondansetron exhibited emesis or discontinued the study prematurely after surgery (ondansetron, 11%; placebo, 28%; odds ratio = 0.33; P < 0.0001). The number required to treat prophylactically with ondansetron to prevent POV was approximately six. Ondansetron treatment also resulted in fewer patients requiring rescue medication or assumed to have had rescue upon early discontinuation from the study during the postoperative period (ondansetron, 5%; placebo, 10%) and less emesis (0 of 6) after rescue medication when compared with placebo (7 of 21). The incidence of POV and other antiemetic effects of ondansetron were similar in children aged 1-12 mo and 13-24 mo and in children prospectively expected or not expected to require opioids as part of their anesthetic or analgesic management. Ondansetron was well tolerated; the incidence of adverse events considered possibly related to study drug was similar between treatment groups (ondansetron, 1.8%; placebo, 1.5%). IMPLICATIONS: This prospective, randomized, double-blind, placebo-controlled study establishes the efficacy and tolerability of IV ondansetron (0.1 mg/kg) in the prevention of postoperative emesis in 1- to 24-mo-old pediatric patients undergoing elective surgery under general anesthesia.     

Ondansetron dose response curve in high-risk pediatric patients

Study Objective: To establish a dose-response relationship for ondansetron, and to evaluate any effects of oral premedication with metoclopramide in pediatric patients undergoing tonsillectomy and adenoidectomy and strabismus surgery.

Design: Prospective, randomized, double blind study.

Setting: University affiliated, 280-bed pediatric hospital.

Patients: 320 ASA physical status I and II patients between the ages of 2 and 12 years undergoing tonsillectomy and adenoidectomy or strabismus surgery.

Interventions: Patients were randomized to eight investigational groups. Patients in all eight groups underwent a standard anesthetic. Groups 1, 2, 3, and 4 received intravenous (IV) saline or IV ondansetron at doses of 0.05 mg/kg, 0.1 mg/kg and 0.15 mg/kg, respectively. Groups 5, 6, 7, and 8 received oral metoclopramide 0.15 mg/kg as well as IV saline, and ondansetron 0.05 mg/kg, 0.1 mg/kg, or 0.15 mg/kg. Patients were evaluated for emetic episodes prior to and following discharge.

Measurements and Main Results: All doses of ondansetron 0.05 mg/kg, 0.1 mg/kg, and 0.15 mg/kg were significantly more effective than placebo in reducing the incidence of emesis prior to, following discharge, and during the first 24 postoperative hours (p < 0.001). There were no significant differences in the occurrence of emesis between the groups receiving ondansetron 0.05 mg/kg, 0.1 mg/kg, and 0.15 mg/kg. The addition of oral metoclopramide 0.15 mg/kg had no effect on the incidence of emesis in the ondansetron or placebo study groups.

Conclusions: Ondansetron is an effective medication for the treatment and prevention of postoperative nausea and vomiting, and a dose of ondansetron 0.05 mg/kg is as effective as 0.1 mg/kg and 0.15 mg/kg. Metoclopramide 0.15 mg/kg has no effect on the incidence of postoperative nausea and vomiting.     

Comparison of cyclizine and ondansetron for the prevention of postoperative nausea and vomiting in laparoscopic day-case gynaecological surgery

Seventy-four patients undergoing laparoscopic gynaecological surgery were randomly allocated to two groups receiving cyclizine 50 mg or ondansetron 4 mg at induction of anaesthesia. Anaesthetic and postoperative analgesia regimens were standardised. Approximately half of the patients in each group experienced some degree of postoperative nausea and vomiting (cyclizine, 56%; ondansetron, 54%). There was no difference between groups in respect of pre- and postdischarge incidence. Mean (SD) time to eye opening was significantly prolonged in the cyclizine group [10 (4) min vs. 8 (2) min; p < 0.001], but this had no influence on discharge times. Cyclizine and ondansetron appear equally effective in preventing postoperative nausea and vomiting but the 10-fold price differential favours cyclizine.     

Efficacy of orally disintegrating ondansetron in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy: a randomised, double-blind placebo controlled study

Peri-operative prophylactic anti-emetics are commonly used parenterally. Orally disintegrating ondansetron is efficacious during chemotherapy. Therefore, we aimed to study the efficacy of orally disintegrating ondansetron for postoperative nausea and vomiting. In a randomised, double-blind, placebo controlled trial on 109 patients scheduled for laparoscopic cholecystectomy, oral ondansetron was compared to intravenous ondansetron and placebo. The anaesthetic technique was standardised. Mean time (SD) to tolerating oral intake was delayed in the placebo group to 366.1 (77.6) min compared to oral 322.9 (63.7) min and intravenous 322.4 (65.2) min groups. This is corroborated by a higher incidence of nausea and vomiting in the control group during the first 6 h postoperatively (control 44.4%, oral 17.7%, intravenous 18.2%). There was no significant difference between oral and intravenous groups. In conclusion, orally disintegrating ondansetron was as efficacious as intravenous ondansetron in the peri-operative phase and may be a viable option for prophylaxis of emesis in day care surgery.     

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.      

The Dose-Response Relationship of Ondansetron in Preventing Postoperative Emesis in Pediatric Patients Undergoing Ambulatory Surgery

Background: Postoperative nausea and vomiting is a distressing anesthetic complication that may delay discharge after ambulatory surgery. Effective prophylaxis for postoperative nausea and vomiting can be achieved in adults with lower doses of ondansetron, a 5-hydroxytryptamine subtype 3 receptor antagonist, compared with chemotherapy-induced emesis. However, the doses of ondansetron used in preventing postoperative nausea and vomiting in children are based on data from chemotherapy-induced emesis. The dose-related efficacy of intravenous ondansetron in the prophylaxis of postoperative emesis in the pediatric outpatient population was determined.

Methods: In a double-blind, randomized placebo-controlled study, 130 patients (mean age 5.7 plus/minus 3.4 yr) received placebo, 10, 50, or 100 micro gram/kg ondansetron during a standardized anesthetic. Episodes of postoperative vomiting or retching were recorded.

Results: Intravenous ondansetron in a dose of 50 micro gram/kg was more effective than placebo or a dose of 10 micro gram/kg in controlling the incidence and frequency of emesis in the hospital and during the first 24 postoperative hours. Increasing the dose of ondansetron to 100 micro gram/kg intravenously did not significantly reduce the incidence or frequency of emesis compared to 50 micro gram/kg intravenously.     

Ondansetron/promethazine combination or promethazine alone reduces nausea and vomiting after middle ear surgery

STUDY OBJECTIVES: To determine the incidence of postoperative nausea and vomiting when a combination of ondansetron and promethazine is given prophylactically, and to ascertain the effect of postoperative nausea and vomiting on recovery room duration and patient satisfaction. DESIGN: Prospective, randomized, placebo-controlled, double-blind study. SETTING: University-affiliated tertiary-care hospital. PATIENTS: 87 ASA physical status I and II adult patients scheduled for middle ear surgery. INTERVENTIONS: Patients were randomly assigned to receive one of the following interventions intravenously: ondansetron 4 mg (Group 1), promethazine 25 mg (Group 2), ondansetron 2 mg plus promethazine 12.5 mg (Group 3, combination), or placebo (Group 4). MEASUREMENTS AND MAIN RESULTS: Independent, study blinded observers recorded complaints of nausea and number of episodes of vomiting for 24 hours following the patient's first response to commands. All patients were contacted the day after discharge to inquire about nausea and vomiting. The awakening time, postanesthesia care unit and day surgery unit durations, opioid use, and side effects were recorded. At the end of the 24-hour period, the study blinded observers asked patients for an overall assessment of their global anesthesia experience using an 11-point scale. During the 24-hour period, the incidence of postoperative nausea and vomiting was reduced from 74% (placebo) to 39% (promethazine; p = 0.03) and 29% (combination; p = 0.003). Compared with placebo, the severity of vomiting was significantly less in the combination group (p = 0.04). The number of very satisfied patients correlated negatively with the incidence of postoperative nausea and vomiting (p < 0.0001) and with the severity of vomiting (p = 0.003). CONCLUSION: The prophylactic use of an antiemetic with middle ear surgery may reduce postoperative nausea and vomiting over 24 hours, and the ondansetron/promethazine combination or promethazine alone are cost-effective choices. Finally, the combination reduced significantly the severity of vomiting.     

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.     

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.     

The effect of combining dexamethasone with ondansetron for nausea and vomiting associated with fentanyl-based intravenous patient-controlled analgesia

We investigated whether combined dexamethasone and ondansetron is more effective than ondansetron alone in preventing postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia. One hundred and thirty patients undergoing video-assisted thoracoscopic surgery were assigned to either an ondansetron group or a dexamethasone and ondansetron group. In all patients, ondansetron 4 mg was administered at the end of surgery and 12 mg was added to the patient-controlled analgesia solution. The dexamethasone and ondansetron group received dexamethasone 8 mg at the induction of anaesthesia. The overall incidence of nausea and vomiting during the first 48 h postoperatively did not differ between groups (34/61 (56%) vs 28/62 (45%) in the ondansetron group and dexamethasone and ondansetron groups, respectively). The incidence of severe nausea and vomiting (≥ 7 nausea on an 11-point verbal numerical rating scale, retching or vomiting) was higher in the ondansetron group than in the dexamethasone and ondansetron group (15/61 (25%) vs 6/62 (10%, respectively, p=0.028). Combined dexamethasone and ondansetron is more effective in reducing severe nausea and vomiting than ondansetron alone in patients receiving fentanyl-based intravenous patient-controlled analgesia.     

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.