A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. [Postoperative vomiting]. A randomized, double-blinded comparison of ondansetron, droperidol, and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy. The prevention of emesis in plastic surgery: a randomized, prospective study. Postoperative analgesia and antiemetic efficacy after intrathecal neostigmine in patients undergoing abdominal hysterectomy during spinal anesthesia. Tropisetron vs ondansetron for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy: a randomized double-blind, placebo-controlled study. Preoperative transdermal scopolamine does not reduce the level of nausea and frequency of vomiting after laparoscopic cholecystectomy. Randomized, double-blinded comparison of tropisetron and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy. Effect and placebo effect of acupressure (P6) on nausea and vomiting after outpatient gynaecological surgery.
Untreated, one third of patients who undergo surgery will have postoperative nausea and vomiting. Although many trials have been conducted, the relative benefits of prophylactic antiemetic interventions given alone or in combination remain unknown.
                We enrolled 5199 patients at high risk for postoperative nausea and vomiting in a randomized, controlled trial of factorial design that was powered to evaluate interactions among as many as three antiemetic interventions. Of these patients, 4123 were randomly assigned to 1 of 64 possible combinations of six prophylactic interventions: 4 mg of ondansetron or no ondansetron; 4 mg of dexamethasone or no dexamethasone; 1.25 mg of droperidol or no droperidol; propofol or a volatile anesthetic; nitrogen or nitrous oxide; and remifentanil or fentanyl. The remaining patients were randomly assigned with respect to the first four interventions. The primary outcome was nausea and vomiting within 24 hours after surgery, which was evaluated blindly.
                Ondansetron, dexamethasone, and droperidol each reduced the risk of postoperative nausea and vomiting by about 26 percent. Propofol reduced the risk by 19 percent, and nitrogen by 12 percent; the risk reduction with both of these agents (i.e., total intravenous anesthesia) was thus similar to that observed with each of the antiemetics. All the interventions acted independently of one another and independently of the patients' baseline risk. Consequently, the relative risks associated with the combined interventions could be estimated by multiplying the relative risks associated with each intervention. Absolute risk reduction, though, was a critical function of patients' baseline risk.
                Because antiemetic interventions are similarly effective and act independently, the safest or least expensive should be used first. Prophylaxis is rarely warranted in low-risk patients, moderate-risk patients may benefit from a single intervention, and multiple interventions should be reserved for high-risk patients.
                Copyright 2004 Massachusetts Medical Society Nausea and vomiting following general anaesthesia are among the most frequent adverse reactions causing complications, the relief of which is an absolute demand. 5-HT3 receptor antagonists, such as ondansetron, belonging to the latest class of antiemetics were launched more than a decade ago.
                Efficacy and tolerability of ondansetron injection in prevention of postoperative nausea and vomiting were investigated in a prospective, randomised, double-blind, placebo controlled, three-armed clinical study in 148 patients undergoing laparoscopic cholecystectomy. Moreover the authors also investigated the effect of timing of dosing, i.e. whether the administration of antiemetic drug before starting anaesthesia has any advantage comparing its use at the end of operation.
                While using a standard surgical and anaesthesia method vomiting after laparoscopic cholecystectomy occurred in a frequency of 44.7% of the patients in the placebo group, whereas the figures decreased significantly after administration of 4 mg ondansetron at the end (28.9%) or before (25.5%) anaesthesia. Inclusively the frequency of severe cases decreased from 19.2% of control group up to 8.9% and 4.3% in the active groups, respectively.
                Intravenous administration of 4 mg ondansetron effectively reduces vomiting occurring in more than 40% of patients after laparoscopic cholecystectomy, especially the frequency of severe cases, and mainly if administered before operation. The preparation is safe; no clinical or laboratory adverse reactions, complications have been observed in the studied patients. 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. Perhaps the most unpleasant experience following outpatient plastic surgery procedures is postoperative nausea and vomiting. Postoperative nausea and vomiting often results in delayed recovery time and unintended admission, and it can be a contributing factor to the formation of hematoma following rhytidectomy. Ondansetron (Zofran) has proven benefit in preventing postoperative nausea and vomiting if given before general anesthesia in a variety of surgical procedures. Its utility in cases performed under conscious sedation has not been determined. The purpose of this study was (1) to test the ability of prophylactic ondansetron to prevent postoperative nausea and vomiting in plastic surgery cases performed under conscious sedation, and (2) to determine relative risk factors for postoperative nausea and vomiting and a selection policy for the administration of antiemetic prophylaxis. This was a prospective, randomized, double-blind study. One hundred twenty patients were enrolled after giving informed consent. Patients received a single dose of either placebo or ondansetron (4 mg intravenously) before administration of sedation. Sedation administration followed a standardized institutional protocol, using midazolam and fentanyl. Data were recorded from a series of three questionnaires: preoperatively, immediately postoperatively, and at the time of the first office return. Data were confirmed by means of telephone interview, chart analysis, and nursing documentation. Multivariate analysis was conducted. Nausea and emesis occurred with an overall frequency of 33 percent and 22 percent, respectively. Postoperative nausea and vomiting was associated with statistically longer recovery periods. The incidence of emesis was statistically higher among women, among those undergoing facial rejuvenation, and among those with a history of opioid-induced emesis or postoperative nausea and vomiting following a previous operation (p < 0.05). The incidence of postoperative nausea and vomiting paralleled increases in case duration; the incidence of emesis was zero in cases less than 90 minutes in duration. Ondansetron significantly reduced the incidence of emesis overall (placebo, 30 percent; ondansetron, 13 percent; p < 0.05). Postoperative perception of nausea was significantly lower among those who had received ondansetron (p < 0.05). These results confirm the efficacy of ondansetron for the prevention of postoperative nausea and vomiting in plastic surgery cases under conscious sedation. In those who are at increased risk, prophylaxis should be considered. Such risks include female gender, facial rejuvenation procedures, and a patient history of opioid-induced emesis or postoperative nausea and vomiting following a prior operation. The zero incidence of emesis in cases less than 90 minutes does not support the routine use of prophylaxis in such cases. Patient satisfaction in plastic surgery is derived from the overall subjective experience of the event as much as by the final result. By remaining attentive to patient concerns and optimizing perioperative care, we can improve the subjective experience for our patients. Postoperative analgesia and antiemetic efficacy after intrathecal neostigmine were investigated in a randomized, double-blind, placebo-controlled trial of 100 patients undergoing abdominal hysterectomy.
                The patients were assigned to one of five groups (n = 20), and received intravenous prior to the spinal block the antiemetic test drug (except propofol) and 0.05 mg/kg midazolam. The control group (group C), the neostigmine group (group N), and the propofol group (group P) received saline as the test drug. The droperidol group (group D) received 0.5 mg intravenous droperidol, and the metoclopramide group (group M) 10 mg intravenous metoclopramide. Group P was single-blinded and had an intravenous continuous propofol infusion (2-4 mg/kg/h) turned on 10 minutes after the spinal injection. The intrathecal drugs administered were 20 mg hyperbaric bupivacaine (0.5%) associated with either 100 microg neostigmine or saline (for group C). Nausea, emetic episodes, and the need for rescue medication were recorded for the first 24 hours postoperative and scored by the Visual Analog Scale (VAS).
                Time-to-first-rescue medication and rescue medications in 24 hours were similar among the groups (P = .2917 and P = .8780, respectively). Intrathecal 100 microg neostigmine was associated with a high incidence of nausea and vomiting perioperative, leading to a high consumption of antiemetics (P < .002). None of the antiemetic test drugs were effective in preventing nausea and vomiting after 100 microg neostigmine.
                Intrathecal neostigmine (100 microg) was ineffective for postoperative analgesia after abdominal hysterectomy due to side effects of nausea and vomiting. 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.
                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.
                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.
                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. To determine the efficacy of scopolamine administered transdermally before laparoscopic cholecystectomy as a means of reducing postoperative nausea and vomiting.
                A randomized, double-blind, placebo-controlled study.
                A tertiary-care, university-affiliated hospital.
                A volunteer sample of 125 men and women between 20 and 60 years of age scheduled to undergo elective laparoscopic cholecystectomy. Expectant or nursing mothers were excluded, and 35 patients were excluded from the final analysis because of protocol violations. Forty-three patients received scopolamine and 47 patients received a placebo.
                A skin patch (scopolamine or placebo) was applied behind the right ear on the evening before operation and maintained for at least 24 hours postoperatively.
                The postoperative level of nausea assessed by the patient on a visual analogue scale, the frequency of vomiting and the frequency of antiemetic use.
                There was no significant difference in the level of nausea or in the frequency of emesis or use of antiemetics in the first 24 hours postoperatively between the control and study groups. Furthermore, there was no difference in the overall frequency of side effects. However, visual blurring was experienced by six patients in the study group compared with one in the control group (p = 0.082).
                Scopolamine administered transdermally before laparoscopic cholecystectomy does not reduce the frequency or level of nausea and vomiting postoperatively. This prospective, randomized, placebo-controlled, double-blinded study was designed to evaluate the efficacy of tropisetron in preventing postoperative nausea and vomiting after elective supratentorial craniotomy in adult patients. We studied 65 ASA physical status I-III patients aged 18 to 76 years who were undergoing elective craniotomy for resection of various supratentorial tumors. Patients were divided into two groups and received either 2 mg of tropisetron (group T) or saline placebo (group P) intravenously at the time of dural closure. A standard general anesthetic technique was used. Episodes of nausea and vomiting and the need for rescue antiemetic medication were recorded during 24 hours postoperatively. Demographic data, duration of surgery and anesthesia, and sedation scores were comparable in both groups. Nausea occurred in 30% of group T patients and in 46.7% of group P patients (P >.05). The incidence of emetic episodes was 26.7% and 56.7% in the two groups (P <.05). Rescue antiemetic medication was needed in 26.7% and 60% of the patients (P <.05). Administration of a single dose of tropisetron (2 mg intravenously) given at the time of dural closure was effective in reducing postoperative nausea and vomiting after elective craniotomy for supratentorial tumor resection in adult patients. Acupuncture and acupressure have previously been reported to possess antiemetic effect. We wanted to investigate the "true" and placebo effect of acupressure in prevention of postoperative nausea and vomiting (PONV).
                Sixty women undergoing outpatient minor gynaecological surgery were entered into a double-blind and randomised study. One group received acupressure with bilateral stimulation of P6 (A), a second group received bilateral placebo stimulation (P) and a third group received no acupressure wrist band and served as a reference group (R). PONV was evaluated as number of patients with complete response (no PONV), nausea only or vomiting. In addition, the need for rescue antiemetic medication and nausea after 24 h was registered.
                Complete response was obtained in 11, 11 and 9 patients in groups, A, P and R, respectively. Nine, 7 and 6 patients had nausea before discharge home, and 1, 1 and 8 patients were nauseated (8 vs 1 patient: P < 0.05) 24 h after operation in A, P and R groups, respectively. When compared to placebo acupressure (2 patients vomited and 5 needed rescue), significantly (P < 0.05) fewer needed rescue antiemetic medication after acupressure at P6 (no vomiting or rescue medication). When compared to the observation group (5 vomited and 4 needed rescue antiemetics), significantly fewer vomited after acupressure (P < 0.05)
                In patients undergoing brief gynaecological surgery, placebo effect of acupressure decreased nausea after 24 h but vomiting and need of rescue antiemetics was reduced only by acupressure with the correct P6 point stimulation.
Either nausea or vomiting is reported to affect, at most, 80 out of 100 people after surgery. If all 100 of these people are given one of the listed drugs, about 28 would benefit and 72 would not. Nausea and vomiting are usually less common and, therefore, drugs are less useful. For 100 people, of whom 30 would vomit or feel sick after surgery if given placebo, 10 people would benefit from a drug and 90 would not. Between one to five patients out of every 100 people may experience a mild side effect, such as sedation or headache, when given an antiemetic drug. Collaborative research should focus on determining whether antiemetic drugs cause more severe, probably rare, side effects. Further comparison of the antiemetic effect of one drug versus another is not a research priority.