Double-blind comparative study of droperidol, granisetron and granisetron plus dexamethasone as prophylactic anti-emetic therapy in patients undergoing abdominal, gynaecological, breast or otolaryngological surgery

In this double-blind study the clinical efficacy of a single pre-operative intravenous dose of droperidol 1.25 mg (137 patients), granisetron 1 mg (130 patients) and granisetron 1 mg plus dexamethasone 5 mg (130 patients) was investigated for the prevention of postoperative nausea and vomiting after gynaecological surgery, breast surgery, abdominal surgery and ear, nose and throat surgery. The incidence of nausea in the first 24 h postoperatively was 52% in the droperidol group, 48% in the granisetron group and 34% with the combination, respectively. Both granisetron and granisetron/dexamethasone performed better than droperidol in their effects on vomiting or combined nausea and vomiting (incidence in the first 24 h 22%, 18% and 42%, respectively). The number of emetic episodes during the 5-day study period was significantly higher in the droperidol group (198) than in the granisetron (73) or combination group (78).     

Prophylactic antiemetic therapy with granisetron-dexamethasone combination in women undergoing breast surgery

Background: Dexamethasone decreases chemotherapy-induced emesis when added to an antiemetic regimen. This study was undertaken to evaluate the efficacy of granisetron-dexamethasone combination for the prevention of postoperative nausea and vomiting (PONV) in female patients undergoing general anaesthesia for breast surgery.
Methods: In a randomized, double-blind manner, 135 ASA I patients, aged 40–65 years, were assigned to receive placebo (saline), granisetron 40 μg · kg⁻¹ or granisetron 40 μg · kg⁻¹ plus dexamethasone 8 mg i.v. (n=45 of each) immediately before the induction of anaesthesia. A standard general anaesthetic technique and postoperative analgesia were used. The PONV and safety assessments were performed continuously during the first 3 h (0–3 h) and the next 21 h (3–24 h) after anaesthesia.
Results: A complete response, defined as no PONV and no administration of rescue antiemetic medication, during 0–3 h after anaesthesia was 51%, 82% and 96% in patients who had received placebo, granisetron and granisetron-dexamethasone combination, respectively; the corresponding incidence during 3–24 h after anaesthesia was 56%, 84% and 98% ( P <0.05; overall Fisher's exact probability test). No clinically important adverse events were observed in any of the groups.
Conclusion: Prophylactic use of granisetron-dexamethasone combination is more effective than granisetron alone for the prevention of PONV after breast surgery.     

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.     

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.     

Randomized prospective double-blind placebo-controlled trial of effect of intravenous ondansetron on intraocular pressure during ophthalmic surgery

The effect of i.v. ondansetron, before induction of anaesthesia,on intraocular pressure (IOP) in patients undergoing cataractsurgery was investigated. Forty patients (two groups of 20)received either ondansetron 4 mg (treatment group) or 0.9% saline(placebo group) in a double-blind controlled manner. There wereno significant differences in IOP between the groups. Ondansetronhad no significant effect on IOP during the study period. Br J Anaesth 2001; 87: 629–31     

Prophylactic ondansetron for postoperative emesis.Meta-analysis of its effectiveness in patients with previous history of postoperative nausea and vomiting

BACKGROUND: The objective of this study was to compare, by means of meta-analysis, the postoperative antiemetic efficacy of ondansetron in patients with and without antecedents of postoperative nausea and vomiting. METHODS: MEDLINE and EMBASE databases were searched for randomised placebo-controlled trials which evaluated the antiemetic effectiveness of 4 mg and 8 mg intravenous doses of prophylactic ondansetron in adult patients. A further selection was with respect to those studies which noted the patient's previous history of postoperative nausea and vomiting (PH-PONV) and, for the meta-analysis, the patients were divided into two sub-groups: those with (PH-PONV +) and those without a previous history of postoperative nausea and vomiting (PH-PONV -). Absence of vomiting was used as the index of effectiveness. RESULTS: Twenty-one trials involving 3984 patients (2446 in ondansetron groups and 1538 in placebo groups; 1163 PH-PONV(+) patients and 2821 PH-PONV(-) patients) met the selection criteria. The effectiveness of the 4 mg dose of ondansetron was: OR (95% CI)=2.40 (1.77-3.26) vs. 2.71 (2.23-3.30) for the patients of PH-PONV(+) and PH-PONV(-) sub-groups, respectively. For the 8 mg dose, the effectiveness of ondansetron was: PH-PONV(+)=4.21 (2.66-6.66) and PH-PONV(-)=2.61 (1.81-3.59). For neither of the doses evaluated was there any significant statistical difference between the sub-groups. CONCLUSIONS: The effectiveness of ondansetron in the prevention of postoperative vomiting is not affected by the patients' PH-PONV.     

Prophylactic therapy with granisetron in the prevention of vomiting after paediatric surgery. A randomized, double-blind comparison with droperidol and metoclopramide

The antiemetic efficacy of droperidol, metoclopramide and granisetron was compared with placebo in the reduction of vomiting after paediatric surgery (the extremities; inguinal hernia; and phimosis) during general inhalational anaesthesia. One hundred children, ASA physical status I, 4–10 years of age, were enrolled in a prospectively, randomized, double-blind investigation and assigned to one of four treatment regimens: placebo (saline, n=25), droperidol (50 μg·kg¹, n=25), metoclopramide (0.25 mg·kg-¹, n=25) or granisetron (40 μg·kg^-1, n=25). These drugs were administered intravenously (iv) after inhalation induction of anaesthesia. A complete response, defined as no emesis and no need for another rescue antiemetic during the first 24 h after anaesthesia, occurred in 60%, 76%, 68% and 88% of patients who had received placebo, droperidol, metoclopramide and granisetron, respectively (P<0.05; overall Fisher's exact probability test). The incidence of adverse events postoperatively was not different among the treatment groups. In conclusion, granisetron 40 μg·kg^-1 is a better antiemetic than droperidol and metoclopramide when compared to placebo for the prevention of postoperative emesis in children.     

Prevention of postoperative nausea and vomiting after spinal morphine for Caesarean section: comparison of cyclizine,dexamethasone and placebo

Background. Low-dose intrathecal (spinal) morphine (0.1–0.2mg) for Caesarean section delivers excellent postoperative analgesiabut is associated with significant nausea and vomiting. We comparedthe antiemetic efficacy of cyclizine, dexamethasone, and placeboin this clinical setting. Methods. Ninety-nine women undergoing elective Caesarean sectionunder spinal anaesthesia were allocated randomly, in a double-blindstudy design, to receive either cyclizine 50 mg, dexamethasone8 mg, or placebo as a single-dose infusion in saline 0.9%, 100ml on completion of surgery. Spinal anaesthesia consisted of:hyperbaric bupivacaine 0.5%, 2.0 ml; fentanyl 10 µg; andspinal morphine 0.2 mg. The primary outcome measure was theincidence of nausea. Results. The incidence of nausea was significantly less in patientsreceiving cyclizine compared with dexamethasone and placebo(33 vs 60 and 67%, respectively, P<0.05). Severity of nauseaand number of vomiting episodes were also less at 3–6h in cyclizine patients. Overall satisfaction with postoperativecare at 24 h, expressed on a 100 mm visual analogue scale, wasgreater in cyclizine [78 (28)] than either dexamethasone [58(31), P=0.03] or placebo [51 (28), P=0.008]. Conclusion. We conclude that following spinal morphine 0.2 mgand fentanyl 10 µg analgesia for Caesarean section, cyclizine50 mg i.v. reduces the incidence of nausea compared with dexamethasone8 mg i.v. or placebo. It also lessens the severity of nauseaand vomiting, and increases maternal satisfaction in the earlypostoperative period. Br J Anaesth 2003; 90: 665–70     

Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy

BACKGROUND: Postoperative vomiting (POV) is a major cause of morbidity after tonsillectomy in children. It has been well established that anti-serotinergic agents are effective for the prophylactic control of POV in this patient group. It has been suggested that at moderate doses (0.5 mg kg(-1)), metoclopramide is also an effective agent. No study has been performed comparing the efficacy of an anti-serotinergic agent and moderate-dose metoclopramide. METHODS: A total of 557 children undergoing tonsillectomy with or without adenoidectomy were randomly allocated to receive either ondansetron 0.1 mg kg(-1) or metoclopramide 0.5 mg kg(-1). All received a standardized muscle-relaxant anaesthetic and dexamethasone 0.1 mg kg(-1). The primary outcome was any vomit in the immediate postoperative period. Comparisons were made of the proportion in each group reaching the primary outcome and the time until their first vomit. The study was designed to detect equivalence. RESULTS: The incidence of vomiting in the group receiving ondansetron (25.3%) was 12% lower (95% CI 4.4-19.7) than those in metoclopramide (37.3%). The time until first vomit was significantly longer in the group receiving ondansetron (hazard ratio 0.61, 95% CI 0.45-0.82). CONCLUSIONS: Although the incidence of vomiting was similar, when these results are compared with a pre-specified zone of equivalence of 0-15%, it cannot be concluded that the effect of metoclopramide is equivalent to ondansetron. Survival analysis indicated that those in the metoclopramide group vomited substantially earlier. It is concluded, therefore, that ondansetron 0.1 mg kg(-1) is a superior drug to metoclopramide 0.5 mg kg(-1) for the prophylactic control of POV in children undergoing tonsillectomy.     

Effect and placebo effect of acupressure (P6) on nausea and vomiting after outpatient gynaecological surgery

BACKGROUND: 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). PATIENTS AND METHODS: 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. RESULTS: 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) CONCLUSION: 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.     

Postoperative nausea, vomiting, airway morbidity, and analgesic requirements are lower for the ProSeal laryngeal mask airway than the tracheal tube in females undergoing breast and gynaecological surgery

Background: We test the hypothesis that the frequency of postoperative nauseaand vomiting is similar for the ProSeal laryngeal mask airway(LMA) and the tracheal tube. Methods: Two hundred consecutive female patients (ASA I–II, 18–75yr) undergoing routine breast and gynaecological surgery weredivided into two equal-sized groups for airway management withthe ProSeal LMA or tracheal tube. Results: Ventilation was better and airway trauma less frequent for theProSeal LMA. For the ProSeal group, the time spent in the post-anaesthesiacare unit was shorter (69 vs 88 min, P < 0.0001); fewer dosesof tropisetron were required in the post-anaesthesia care unit(P 0.001) and ward (P = 0.004); morphine requirements werelower in the post-anaesthesia care unit (6.0 vs 8.1 mg, P =0.005) and ward (6.1 vs 8.9, P = 0.004); nausea was less frequentat all times (overall: 13% vs 53%, P < 0.0001); vomitingwas less frequent at 2 h (4% vs 18%, P = 0.003) and 24 h (5%vs 19%, P = 0.004); and sore throat was less frequent at alltimes (overall: 12% vs 38%, P < 0.0001). Conclusions: The ProSeal LMA reduced the absolute risk of postoperative nauseaand vomiting by 40% (53–13%). In patients without theneed for morphine, the ProSeal LMA reduced the absolute riskof postoperative nausea and vomiting by 23% (37–14%).We conclude that the frequency of postoperative nausea, vomiting,airway morbidity, and analgesic requirements is lower for theProSeal LMA than the tracheal tube in females undergoing breastand gynaecological surgery.     

Prevention of nausea and vomiting in female patients undergoing breast surgery: A comparison with granisetron, droperidol, metoclopramide and placebo

Background : Breast surgery is associated with a relatively high incidence of postoperative nausea and vomiting (PONV). This study was undertaken to evaluate the efficacy of granisetron, droperidol and metoclopramide for preventing PONV after breast surgery.
Methods : In a randomized, double-blind, placebo-controlled trial, 120 female patients received granisetron 40μg.kg^-1, droperidol 1.25 mg, metoclopramide 10 mg or placebo (saline) (n=30 for each) intravenously immediately before the induction of anaesthesia. A standard general anaesthetic technique was employed throughout. Postoperatively, during the first 24 h after anaesthesia, the incidence of PONV and adverse events was recorded.
Results : The incidence of PONV was 17% with granisetron, 37% with droperidol, 43% with metoclopramide and 50% with placebo ( P <0.05; overall Fisher's exact probability test). The incidence of adverse events was not different among the groups.
Conclusion : Granisetron is highly effective for reducing the incidence of PONV in female patients undergoing breast surgery. Droperidol and metoclopramide are ineffective in this population.     

A comparison of prophylactic ondansetron and metoclopramide administration in patients undergoing major neurosurgical procedures

In a prospective, randomised, double-blind trial, we assessed the relative efficacy of prophylactic ondansetron and metoclopramide administration in the reduction of postoperative nausea and vomiting in 60 patients undergoing routine major neurosurgical procedures. The patients were randomly allocated into one of two groups. Both groups received a standardised anaesthetic. When the dura mater was closed, patients in group A received an intravenous injection of metoclopramide 10 mg whilst group B received ondansetron 8 mg intravenously. Patients who received metoclopramide experienced less postoperative nausea and vomiting than those who received ondansetron in the 48 h following surgery (17 (56%) versus 9 (30%) p = 0.038). In the light of these findings, we believe that ondansetron is an inappropriate agent for the prevention of postoperative nausea and vomiting in the neurosurgical population.     

A prospective randomized blinded study of the effect of intravenous fluid therapy on postoperative nausea and vomiting in children undergoing strabismus surgery

BACKGROUND: Nausea and vomiting is a common postoperative complication that often necessitates the use of antiemetic agents. METHODS: In a prospective, randomized, double blind trial, the effect of perioperative fluid administration on postoperative adverse outcomes following anesthesia was studied. One hundred children undergoing strabismus repair were randomly assigned to receive 10 ml x kg(-1) x h(-1) (control group) or 30 ml x kg(-1) x h(-1) (superhydration group) of lactated Ringer's solution during the operation. During the first 24 h postoperatively, nausea and vomiting, thirst, pain, and fever were evaluated. RESULTS: Groups were similar with respect to demographic data, surgical procedures and baseline hemodynamic variables. In the first 24 h postoperatively, nausea and vomiting occurred in 27 patients (54%) of the control group and 11 (22%) of patients in the superhydration group (P = 0.001). Comparison of the superhydration group with the control group also showed a statistically significant benefit of superhydration on postoperative thirst (P = 0.0002) and fever (P = 0.02). The differences in nausea and vomiting, thirst, and fever remained significant after adjustment for age, gender, weight, and duration of surgery. There was no significant difference between the two groups in postoperative pain. CONCLUSIONS: Intravenous superhydration administration is an inexpensive and safe therapy for reducing postoperative nausea and vomiting and discomfort.     

几种药物预防腹腔镜胆囊切除术后恶心呕吐的对比研究

目的比较格拉司琼、氟哌利多、地塞米松单用或合用预防腹腔镜胆囊切除术后恶心呕吐的效果。方法择期腹腔镜胆囊切除术患者160例,于麻醉前随机分为四组,静脉注入各预防性药物,A组：地塞米松10mg;B组：氟哌利多2．5mg;C组：氟哌利多2．5mg＋地塞米松10mg;D组：格拉司琼3mg。观察术后24h恶心呕吐发生率。结果四组术后24h恶心呕吐总发生率分别为78％、63％、25％、28％,C组和D组明显低于A组和B组（P〈0．01）,而C组与D组差异无统计学意义。结论格拉司琼、氟哌利多、地塞米松都有预防腹腔镜胆囊切除术后恶心呕吐的作用,但以格拉司琼和氟哌利多＋地塞米松效果显著,而且氟哌利多＋地塞米松更显示其性价比优越性。     

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.