A comparison of cyclizine,ondansetron and placebo as prophylaxis against postoperative nausea and vomiting in children

Nausea and vomiting is a relevant and common problem with unfavourable sequelae in children undergoing some plastic surgery procedures. There is a lack of anti-emetic trials performed in children, with only a few investigating the roles of the older anti-emetic agents such as cyclizine compared with newer ones such as ondansetron. This randomised, controlled, double-blind study examined the effectiveness of a single dose of ondansetron (0.1 mg x kg-1), cyclizine (20 mg) and placebo (normal saline) in the prevention of postoperative nausea and vomiting in 150 children (mean age 3.6 years) undergoing plastic genitourinary procedures. Rates of previous postoperative nausea and vomiting and motion sickness were comparable across the groups. Postoperative vomiting was significantly reduced with ondansetron prophylaxis (p = 0.006) but there was no detectable anti-emetic effect with cyclizine. Furthermore, cyclizine caused pain on injection (p < 0.001).     

Prevention of post-operative nausea and vomiting with combined granisetron and droperidol in women undergoing thyroidectomy

We have compared the efficacy and safety of combined granisetron and droperidol with each anti-emetic alone for preventing post-operative nausea and vomiting after thyroidectomy. In a prospective, randomized, double-blind study, 180 women received granisetron 40 micrograms kg-1, droperidol 20 micrograms kg-1, or granisetron 40 micrograms kg-1 plus droperidol 20 micrograms kg-1 (n = 60 of each) intravenously immediately before induction of anaesthesia. A standard general anaesthetic technique and post-operative analgesia were used. A complete response, defined as no post-operative nausea and vomiting and no need for another rescue anti-emetic, during the first 24 h after anaesthesia occurred in 88%, 60% and 98% of patients who had received granisetron, droperidol and granisetron plus droperidol (P < 0.05; overall Fisher's exact probability test). No clinically important adverse events due to the drugs were observed in any of the groups. In summary, prophylactic use of combined granisetron and droperidol is more effective than each drug alone for the prevention of post-operative nausea and vomiting in female patients undergoing thyroidectomy.     

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.     

Prophylactic anti-emetic therapy with granisetron, droperidol and metoclopramide in female patients undergoing middle ear surgery

The efficacy of granisetron, droperidol and metoclopramide for the prevention of postoperative nausea and vomiting in female patients undergoing middle ear surgery was compared. In a randomised, double-blind study, 180 patients received granisetron 40 micrograms.kg-1, droperidol 20 micrograms.kg-1 or metoclopramide 0.2 mg.kg-1 given intravenously immediately before induction of anaesthesia (n = 60 for each). A standardised general anaesthetic technique was employed throughout. A complete response, defined as no postoperative nausea and vomiting and no need for another rescue anti-emetic, during the first 3 h after anaesthesia was achieved in 83%, 58% and 55% of patients who had received granisetron, droperidol and metoclopramide, respectively. The corresponding incidence during the next 21 h after anaesthesia was 85%, 54% and 47% (p < 0.05). No clinically important adverse effects were observed in any of the groups. We conclude that prophylactic therapy with granisetron is superior to droperidol or metoclopramide in the prevention of postoperative nausea and vomiting after middle ear surgery.     

Granisetron/dexamethasone combination for the prevention of postoperative nausea and vomiting after thyroidectomy

This study was undertaken to evaluate the efficacy of granisetron plus dexamethasone for preventing postoperative nausea and vomiting (PONV) after thyroidectomy. In a prospective, randomized, double-blind study, 130 female patients received either granisetron 40 micrograms/kg or granisetron 40 micrograms/kg plus dexamethasone 8 mg intravenously immediately before the induction of anaesthesia (n = 65 in each group). A standard general anaesthetic technique was used. A complete response (no PONV, no rescue) during the first three hours after anaesthesia occurred in 85% of patients with granisetron alone and 98% with granisetron plus dexamethasone; the corresponding incidence for the period 3 to 24 hours after anaesthesia was 86% and 98% (P < 0.05; Fisher's exact probability test). No clinically serious adverse events were observed in any of the groups. In conclusion, prophylactic use of granisetron/dexamethasone combination is more effective than granisetron alone for preventing PONV in women undergoing thyroidectomy.     

Preoperative oral granisetron for the prevention of postoperative nausea and vomiting after breast surgery.

OBJECTIVE: To evaluate the efficacy and safety of oral granisetron for the prevention of postoperative nausea and vomiting after breast surgery. DESIGN: Prospective, randomised, double-blind, placebo-controlled study. SETTING: University affiliated hospital, Japan. SUBJECTS: 100 women listed for partial or modified radical mastectomy with or without axillary dissection. INTERVENTIONS: Patients were given either placebo or granisetron in three different doses (1 mg, 2 mg, 4 mg) orally 1 hour preoperatively (n = 25 in each group). A standard general anaesthetic technique and postoperative analgesia were used. MAIN OUTCOME MEASURES: All episodes of nausea and vomiting during the first 24 hours after anaesthesia. RESULTS: Complete response, defined as no nausea and vomiting and no need for a "rescue" antiemetic, during the first 24 hours after anaesthesia was recorded in 13 (52%) with placebo, 14 (56%) with granisetron 1 mg, 22 (88%) with 2 mg, and 22 (88%) with 4 mg, respectively (p = 0.006, Fisher's exact test). No clinically serious adverse events were seen in any of the groups. CONCLUSION: Preoperative oral granisetron, in doses of more than 2 mg, is effective for the prevention of postoperative nausea and vomiting in women undergoing general anaesthesia for breast surgery.     

Superior anti-emetic efficacy of granisetron-dexamethasone combination in children undergoing middle ear surgery

AIM: To compare the effectiveness of granisetron and a granisetron-dexamethasone combination for the prevention of post-operative vomiting in children undergoing middle ear surgery. METHODS: Ninety ASA physical status I or II children, aged 3-12 years, were randomly assigned to three groups of 30 each to receive a single dose of placebo (normal saline), granisetron 40 microg/kg or a combination of granisetron 40 microg/kg and dexamethasone 150 microg/kg intravenously after the induction of anaesthesia. Peri-operative anaesthetic care was standardized in all children. Post-operatively, during the first 24 h after anaesthesia, the frequencies of retching and vomiting and the incidence of adverse events were recorded. Rescue anti-emetic was administered if two or more episodes of emesis occurred. Post-operative pain was treated with morphine intravenously, followed by acetaminophen orally. RESULTS: There were no differences between the treatment groups with regard to demographic data. A complete response (no retching/vomiting and no need for rescue anti-emetic) was achieved in 50%, 80% and 96.67% of children who received saline, granisetron and granisetron-dexamethasone, respectively (P < 0.05). Six children who received placebo and one who received granisetron alone required another rescue anti-emetic. The incidence of adverse events was comparable in the three groups. CONCLUSION: The prophylactic granisetron-dexamethasone combination was more effective than granisetron alone in the prevention of post-operative emesis during the first 24 h after anaesthesia in children undergoing middle ear surgery.     

Prophylaxis with oral granisetron for the prevention of nausea and vomiting after laparoscopic cholecystectomy: a prospective randomized study

HYPOTHESIS: Laparoscopic cholecystectomy is associated with a relatively high incidence of postoperative nausea and vomiting when no prophylactic antiemetic is given. This study assesses the efficacy and safety of oral granisetron hydrochloride for the prevention of nausea and vomiting after laparoscopic cholecystectomy. DESIGN: A prospective, randomized, double-blind, placebo-controlled study. SETTING: University teaching hospital. PATIENTS: The study comprised 120 patients, 92 women and 28 men, undergoing laparoscopic cholecystectomy. INTERVENTIONS: Patients received orally either placebo or granisetron at 3 different doses (1 mg, 2 mg, and 4 mg; n = 30 of each) 60 minutes before surgery. A standard general anesthetic technique and postoperative analgesia were used. MAIN OUTCOME MEASURES: Emetic episodes were recorded during the first 24 hours after anesthesia. RESULTS: The incidence of patients who were emesis-free 24 hours after anesthesia was 60% with 1 mg of granisetron (P =.40), 83% with 2 mg of granisetron (P =.01), and 83% with 4 mg of granisetron (P =.01), compared with placebo (53%). No clinically important adverse effects were observed in any of the groups. CONCLUSION: Preoperative oral granisetron in doses higher than 2 mg is effective for the prevention of nausea and vomiting after laparoscopic cholecystectomy.     

Comparison of granisetron and granisetron plus dexamethasone for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy

BACKGROUND: Laparoscopic cholecystectomies are associated with an appreciably high rate of postoperative nausea and vomiting (PONV). This study was designed to compare the effectiveness of granisetron plus dexamethasone with granisetron alone for the prevention of postoperative nausea and vomiting in patients after laparoscopic cholecystectomy. METHODS: In a randomized, double-blind study, 120 patients of both sexes received granisetron 40 micro g kg-1 alone or granisetron 40 micro g kg-1 plus dexamethasone 8 mg (n=60 of each) intravenously immediately before induction of anesthesia. Perioperative anesthetic care was standardized in all patients. Patients were then observed for 24 h after administration of the study drug. RESULTS: A complete response (defined as no PONV and no need for another rescue antiemetic) was achieved in 83% of the patients given granisetron and in 95% of the patients given granisetron plus dexamethasone (P<0.05). The overall cumulative incidences (0-24 h) of PONV were 11 (18.3%) in the granisetron and three (5%) in the combination group. No difference in adverse events were observed in any of the groups. CONCLUSION: The combination (granisetron plus dexamethasone) further increases the chance of complete response than granisetron alone. Therefore, the combination might be considered clinically relevant in a high risk setting.     

A double-blind, parallel-group, placebo-controlled, dose-ranging, multicenter study of intravenous granisetron in the treatment of postoperative nausea and vomiting in patients undergoing surgery with general anesthesia

Study Objective: To compare the effectiveness of granisetron with placebo in the treatment of established postoperative nausea and vomiting (PONV).

Design: Randomized, placebo-controlled study.

Setting: 34 hospitals in Europe, Scandinavia, and South Africa.

Patients: 519 ASA physical status I, II, and III patients who developed PONV within 4 hours of the end of surgery performed with general anesthesia.

Interventions: Patients received a single intravenous dose of granisetron 0.1 mg, 1 mg, or 3 mg, or placebo when symptoms of nausea or vomiting were experienced. Additional rescue medication could be given at the investigator's discretion if nausea and vomiting were not controlled.

Measurements and Main Results: At all doses investigated, granisetron was significantly more effective (p ≤ 0.001) than placebo in controlling vomiting: 38%, 46%, and 49% of patients receiving granisetron, 0.1 mg, 1.0 mg, and 3.0 mg, respectively, experienced no vomiting in the first 24 hours following drug administration, compared with 20% receiving placebo. There was a statistically significant linear relationship between vomiting control and granisetron dose (p < 0.001). Survival distributions of time to resolution of vomiting confirmed the statistically significant difference between patients receiving granisetron and those receiving placebo. Granisetron was well tolerated: the most common adverse experiences were pain, constipation, anemia, and headache, and the incidence of adverse experiences was not statistically significantly higher in any of the granisetron groups than in the placebo group.

Conclusion: Granisetron was significantly more effective than placebo in all groups. Further studies in specific subgroups may be warranted.     

Prevention of postoperative nausea and vomiting in patients undergoing laparoscopic bariatric surgery--granisetron alone vs granisetron combined with dexamethasone/droperidol

BACKGROUND AND OBJECTIVES: Laparoscopic bariatric surgeries are associated with an appreciably high rate of postoperative nausea and vomiting. This study was designed to compare the effectiveness of granisetron either alone or in combination with droperidol or dexamethasone, for the prevention of post operative nausea and vomiting (PONV) in patients undergoing laparoscopic bariatric surgeries. METHODS: In a randomized, double-blind, placebo-controlled trial, 120 patients received either Granisetron 1 mg, Granisetron 1 mg plus Droperidol 1.25 mg, Granisetron 1 mg plus Dexamethasone 8 mg or Placebo (saline), intravenously immediately before induction of anesthesia. Perioperative anesthetic care was standardized in all patients. Patients were then observed for 24 hours after administration of the study drugs. RESULTS: The incidence of PONV was 30% with granisetron alone, 30% with granisetron plus droperidol, 20%, with granisetron plus dexamethanone, and 67% with placebo. (P < 0.05; overall Fisher's exact probability test). The incidence of adverse events was not different among the 4 groups. CONCLUSION: Graniserton is effective and safe drug for reducing the incidence of PONV in patients undergoing bariatric surgeries, and becomes highly effective when combined with dexamethasone.     

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).     

Comparison of ramosetron and granisetron for preventing postoperative nausea and vomiting after gynecologic surgery.

In a prospective, randomized, double-blinded study, we evaluated the efficacy of granisetron and ramosetron for preventing postoperative nausea and vomiting (PONV) in major gynecologic surgery. One hundred twenty patients, ASA physical status I or II, aged 23-65 yr, received i.v. granisetron 2.5 mg or ramosetron 0.3 mg (n = 60 each) at the end of surgery. A standard general anesthetic technique and postoperative analgesia were used. The incidence of a complete response, defined as no PONV and no need for another rescue medication, 0-3 h after anesthesia was 87% with granisetron and 90% with ramosetron; the corresponding incidence 3-24 h after anesthesia was 85% and 90%; the corresponding incidence 24-48 h after anesthesia was 70% and 92% (P < 0.05). No clinically serious adverse events due to the drugs were observed in any of the groups. In conclusion, prophylactic therapy with ramosetron is more effective than granisetron for the longterm prevention of PONV after major gynecologic surgery. Implications: We compared the efficacy of granisetron and ramosetron for preventing postoperative nausea and vomiting in major gynecologic surgery. Prophylactic therapy with ramosetron was more effective than granisetron for preventing postoperative nausea and vomiting 24-48 h after anesthesia.     

Comparison of methylprednisolone and droperidol in the prevention of nausea and vomiting following major gynaecological surgery]

The efficacy of methylprednisolone (MP) (500 or 250 mg) or droperidol 2.5 mg administered i.v., was studied in 200 women undergoing major gynaecological surgery. Following a standardised general anaesthesia technique with intrathecal morphine, the incidence of nausea and vomiting was assessed. The frequency of postoperative nausea and vomiting in the non-treated group was 59% and 35%; the group of MP 500 mg has a significant reduction of nausea and vomiting to 21% and 13%. Droperidol 2.5 mg decreased the incidence of postoperative nausea alone (nausea: 36%, vomiting: 19%). MP 250 mg was not effective in reducing either nausea or vomiting (nausea: 44%, vomiting: 38%). It was concluded that, of the drugs studied, MP 500 mg was most effective in preventing nausea and vomiting after major gynaecological surgery.     

The influence of cyclizine and perphenazine on the emetic effect of meptazinol

The effectiveness of 50 mg cyclizine and 2.5 mg perphenazine against the emetic sequelae of 100 mg meptazinol were studied in a randomized double-blind placebo-controlled trial. Three groups of 40 women received the opioid, together with an anti-emetic by i.m. injection, as premedication prior to minor gynaecological surgery. Beneficial or noxious effects were noted at standard time intervals and anaesthesia standardized as incremental methohexitone with nitrous oxide/oxygen. In the placebo group, 33 out of 40 subjects experienced either nausea or vomiting at some time after the opioid. Cyclizine, 50 mg, provided significant reduction of emetic tendency in both pre-operative and post-operative phases of the study with 22 out of 40 subjects experiencing nausea or vomiting overall. Perphenazine, 2.5 mg, showed no useful anti-emetic effect. Both anti-emetics increased the soporific effect of premedication at the 90-min interval. Subjects receiving perphenazine experienced significantly more dizziness than those of other groups.     

RETRACTED ARTICLE: Prevention of postoperative nausea and vomiting with granisetron: a randomized,double-blind comparison with droperidol

The effects of granisetron for preventing postoperative nausea and vomiting were investigated in a randomized, double-blind comparison with droperidol and placebo in 100 patients undergoing general anaesthesia for major gynaecological surgery. The patients received a single dose of either granisetron (40 μg · kg^{? 1}, n = 25), dropéridol (1.25 mg, n = 25; 2.5 mg n = 25) or placebo (saline, n = 25) iv over two to five minutes immediately before induction of anaesthesia. The antiemetic effects of these drugs were evaluated during the first three and the next 21 hr after recovery from anaesthesia. During 0– 3 hr after anaesthesia, the frequency of nausea and vomiting was 60%, 12%, 16% and 12% after administration of placebo, granisetron, droperidol 1.25 mg or droperidol 2.5 mg, respectively. The corresponding frequencies during 3– 24 hr after anaesthesia were 44%, 8%, 36% and 12%. The efficacy of granisetron in preventing postoperative nausea and vomiting was almost equal to that of droperidol 2.5 mg. The awakening time in the patients who had received droperidol 2.5 mg was prolonged by approximately three minutes compared with the placebo group (P < 0.05), and postoperative drowsiness/sedation was observed in these patients. In conclusion, preoperative prophylactic administration of granisetron is superior to that of droperidol in the prevention of postoperative nausea and vomiting after anaesthesia.     

Prevention of postoperative nausea and vomiting in female patients during menstruation: comparison of droperidol, metoclopramide and granisetron

The incidence of postoperative nausea and vomiting (PONV) is high in women during menstruation. We have compared the efficacy of droperidol, metoclopramide and granisetron in the prevention of PONV in female patients during menstruation undergoing major gynaecological surgery. In a randomized, double-blind study, 120 patients received droperidol 25 micrograms kg-1, metoclopramide 0.2 mg kg-1 or granisetron 40 micrograms kg-1 (n = 40 in each group) i.v. immediately before induction of anaesthesia. A standard general anaesthetic technique and postoperative analgesia were used throughout. There was a complete response, defined as no PONV and no administration of rescue medication, during the 24-h observation period in 45% of patients in the droperidol group, 38% in the metoclopramide group and 70% in the granisetron group (P = 0.021 vs droperidol, P = 0.003 vs metoclopramide). There was no difference in the incidence of adverse events between groups. We conclude that the prophylactic antiemetic efficacy of granisetron was superior to that of droperidol or metoclopramide for prevention of PONV in women during menstruation.      

Prophylactic anti-emetic efficacy of ondansetron in laparoscopic cholecystectomy under total intravenous anaesthesiaA randomised, double-blind comparison with droperidol, metoclopramide and placebo

The prophylactic anti-emetic efficacy and safety of pre-operative intravenous ondansetron was evaluated in a randomised, double-blind, comparison with droperidol, metoclopramide and placebo in 160 ASA grade 1 and 2 patients undergoing laparoscopic cholecystectomy under total intravenous anaesthesia. The patients were randomly allocated to receive ondansetron (4 mg), droperidol (1.25 mg), metoclopramide (10 mg) or placebo given as a single intravenous dose immediately before induction of a standardised general anaesthetic. There were no significant differences between the four study groups with regard to the demographic and anaesthetic data, postoperative analgesia, postoperative sedation scores, duration of postoperative hospital stay and incidence of adverse events. The incidence of nausea and vomiting was significantly lower (p < 0.05) between 1 h and 4 h after surgery in the ondansetron group compared with the droperidol, metoclopramide and placebo groups. The incidence of nausea was similar in the four groups in the other study periods: 0-1 h and 4-24 h. The incidence of vomiting was lower in the ondansetron, droperidol and metoclopramide groups than in the placebo group between 1 and 4 h but was the same between 4 and 24 h. As a result of the lower incidence of nausea and vomiting between 1 h and 4 h in the ondansetron group, the overall incidence of nausea and vomiting was lower during the first 24 h after surgery in this group than in the other three groups.     

Midazolam vs ondansetron for preventing postoperative nausea and vomiting: a randomised controlled trial

We compared the prophylactic anti-emetic efficacy of midazolam and ondansetron in 90 patients scheduled for minor gynaecological (hysteroscopy) or urological (ureteroscopy) procedures planned to last 1-2 h under sevoflurane anaesthesia with spontaneous ventilation of the lungs via a laryngeal mask airway. Midazolam 2 mg or ondansetron 4 mg were administered intravenously 30 min before the end of surgery. The proportions of patients who experienced postoperative nausea and vomiting in the first 24 h (30% and 27% for the midazolam and ondansetron groups, respectively) were similar in the two groups. The incidence of postoperative nausea and vomiting was significantly smaller in both groups than predicted according to the patients' underlying risks (midazolam group: p = 0.018; ondansetron group: p = 0.017). There were no significant differences in average sedation scores or pain scores. Treatment using ondansetron for anti-emetic prophylaxis did not provide a superior benefit compared to midazolam in the present study.     

COMPARISON OF THE USE OF DOMPERIDONE, DROPERIDOL AND METOCLOPRAMIDE IN THE PREVENTION OF NAUSEA AND VOMITING FOLLOWING MAJOR GYNAECOLOGICAL SURGERY

Domperidone 20 mg, droperidol 2.5 mg, metoclopramide 10 mg andplacebo (saline) were given i.v. 10 min before the end of anaesthesia,to 200 women undergoing major gynaecological surgery, and theincidence of postoperative nausea and vomiting following a standardanaesthetic technique was assessed. Droperidol was significantlymore effective than domperidone, metoclopramide or placebo inreducing emetic sequelae. There were no significant differencesbetween the groups in the incidence of extrapyramidal effectsand postoperative sedation. Patients given droperidol requiredless postoperative analgesia than those given domperidone ormetoclopramide. It was concluded that, of the drugs studied,droperidol alone was effective in protecting against nauseaand vomiting after major gynaecological surgery.