Placebo-controlled comparison of dolasetron and metoclopramide in preventing postoperative nausea and vomiting in patients undergoing hysterectomy

BACKGROUND AND OBJECTIVE: In a randomized, placebo-controlled, double-blind trial, we compared the efficacy of dolasetron and metoclopramide in preventing postoperative nausea and vomiting in women undergoing hysterectomy. METHODS: Patients were allocated randomly to one of three groups: group A (n = 50) received 50 mg dolasetron orally, group B (n = 50) received 20 mg metoclopramide intravenously and placebo orally, group C (n = 50) received placebo orally. If patients complained of retching or vomiting, or if patients demanded an antiemetic, 1.25 mg droperidol was administrated intravenously. To quantify postoperative nausea and vomiting the following score was used: 0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting. The Raatz test was used to analyse postoperative nausea and vomiting (PONV) scores. RESULTS: Dolasetron reduced the postoperative nausea and vomiting score significantly (P < 0.02 vs. metoclopramide; P < 0.0001 vs. placebo). Metoclopramide also reduced the postoperative nausea and vomiting score (P < 0.02 vs. placebo). Fisher's exact test showed a significant reduction of vomiting in the dolasetron group compared with metoclopramide-treated patients (P < 0.007) and placebo-treated patients (P < 0.000006) and a significantly lower rate of nausea in comparison to the placebo group (P < 0.009). There were no significant differences between the metoclopramide and the placebo groups (in Fisher's exact test). The use of postoperative droperidol per patient was significantly lower in the dolasetron group (P < 0.04 vs. metoclopramide; P < 0.0001 vs. placebo) than in the metoclopramide (P < 0.02 vs. placebo) and in the placebo groups. CONCLUSIONS: Oral dolasetron is more effective than either metoclopramide given intravenously or placebo for preventing vomiting after hysterectomy. It also was significantly superior to either metoclopramide or placebo concerning the PONV score and the need for droperidol rescue.     

Granisetron-droperidol combination for the prevention of postoperative nausea and vomiting in female patients undergoing breast surgery

We have compared the efficacy and safety of the combination granisetron- droperidol with each antiemetic alone in preventing postoperative nausea and vomiting (PONV) after breast surgery. In a randomized, double-blind study, 150 female patients received granisetron 3 mg, droperidol 1.25 mg or granisetron 3 mg with droperidol 1.25 mg (n = 50 each) i.v., immediately before induction of anaesthesia. A standard general anaesthetic technique was used. The incidence of PONV during the first 24 h after anaesthesia was 18% with granisetron, 38% with droperidol and 4% with the granisetron-droperidol combination (P < 0.05; overall Fisher's exact probability test). We conclude that the granisetron-droperidol combination was more effective than each antiemetic alone in the prevention of PONV in female patients undergoing breast surgery.      

肺部手术患者术后恶心呕吐的前馈控制管理

目的 降低肺部手术患者术后恶心呕吐发生率.方法 采取前瞻性非同期对照设计,将2020年7月收治的肺部手术患者86例纳入对照组,按肺部手术常规管理;将2020年9月收治的肺部手术患者87例纳入观察组,采取肺部手术后恶心呕吐前馈控制专项管理.结果 观察组肺部手术后恶心呕吐发生率显著低于对照组(P＜0.05).结论 前馈控制应用于肺部手术患者术后恶心呕吐管理,能够降低术后恶心呕吐发生率,利于患者快速康复.     

Frequency of postoperative nausea and vomiting in patients undergoing laparoscopic foregut surgery

Background: Wrap disruption or intrathoracic herniation of a fundoplication is a dreaded complication of laparoscopic foregut surgery. This problem may often be related to postoperative nausea and vomiting (PONV). This study aimed to investigate the occurrence of PONV and its management in patients undergoing laparoscopic foregut procedures. Methods: Between January 31 and May 23, 2000, 104 patients undergoing laparoscopic foregut procedures (fundoplication, myotomy, or paraesophageal hernia repair) were followed prospectively. Their postoperative course was documented along with the occurrence and management of PONV. All laparoscopic foregut surgery patients are managed postoperatively with a uniform clinical pathway, and their care is focused on a nursing unit with skill and experience in postoperative management. Results: Nausea was documented in the postanesthesia care unit (PACU) for 30.1% of the patients, and for 59.6% of the patients during their nursing unit stay. Antiemetics were given to all the patients with documented nausea. Emesis was noted in 1.9% of the patients in the PACU, as compared with 3.8% of the patients on the floor. In one of the patients with nursing unit emesis, an acute wrap herniation into the chest occurred, necessitating a return to the operating room for correction. The patients with a history of postoperative nausea did not have a higher rate of PONV than in those with no history of postoperative nausea. The use of preoperative or intraoperative antiemetics did not appear to alter the occurrence of PONV. Postoperative nausea occurred in 60% of the patients administered preoperative antiemetic, as compared with 64% of the patients who received no preoperative antiemetic. The average length of hospital stay was longer in those with PONV than in those with no PONV (2.6 vs 1.8 days). Conclusion: Nausea after laparoscopic foregut procedures is common, occurring twice as often on the nursing unit as in the PACU. The occurrence of PONV leads to a longer hospital stay, and can result in significant sequelae requiring reoperation. The use of preoperative or intraoperative antiemetics does not alter the frequency of postoperative nausea, suggesting the need to develop effective preemptive regimens for patients undergoing laparoscopic foregut procedures. The high rate of PONV and its potential risk of damage to a fundoplication and hiatal hernia repair should lead surgeons to consider whether laparoscopic foregut procedures should ever be performed on an outpatient basis.     

Transdermal scopolamine patch in addition to ondansetron for postoperative nausea and vomiting prophylaxis in patients undergoing ambulatory cosmetic surgery

Study ObjectiveTo determine the efficacy of transdermal scopolamine in addition to ondansetron in decreasing the incidence of postoperative nausea and vomiting (PONV).DesignRandomized controlled trial.SettingAcademic hospital.Patients126 ASA physical status I and II patients undergoing outpatient plastic surgery with three or more risk factors for PONV.InterventionsPatients were randomly assigned to one of two groups to receive (Group 1) a transdermal scopolamine (TDS) patch or (Group 2), a placebo patch two hours before surgery.MeasurementsOccurrence of vomiting, severity of nausea using a visual analog scale (VAS), rescue medication, pain intensity and pain medications, and side effects were recorded every hour until discharge from hospital, then every 4 hours thereafter for a total of 24 hours.Main ResultsA statistically significant reduction in postoperative nausea between 8 and 24 hours in patients receiving TDS was noted.ConclusionsTransdermal scopolamine in addition to ondansetron benefits patients at high risk for PONV undergoing outpatient plastic surgery for up to 20 hours after surgery.     

Comparison of oral dolasetron and ondansetron in the prophylaxis of postoperative nausea and vomiting in children

BACKGROUND AND OBJECTIVE: In a randomized, placebo-controlled, double-blind trial, we compared the efficacy of oral dolasetron and ondansetron in preventing postoperative nausea and vomiting in children after various surgical operations. METHODS: Children were assigned randomly to one of three groups (each contained 50 children) to receive dolasetron 1.8 mg kg(-1) or ondansetron 0.15 mg kg(-1) orally, or a placebo. All children received methylene blue capsules (10 mg) orally as an indicator before the induction of anaesthesia. Postoperatively, contamination of the mouth and the endotracheal tube by methylene blue was recorded, and postoperative nausea and vomiting was recorded for 0-1, 1-24 and 0-24 h. Metoclopramide (0.1 mg kg(-1)) intravenously was used as the rescue antiemetic. RESULTS: In the 0-1 h period after operation, there were no differences between the groups. In the 1-24 h period, dolasetron was significantly better than placebo (nausea 8 versus 24%; vomiting 4 versus 20%; total nausea and vomiting scores 16 versus 48%). Over the 0-24 h period, both dolasetron and ondansetron were significantly better than placebo (nausea 16 versus 26 versus 40%), vomiting (8 versus 16 versus 30%), and total nausea and vomiting scores (32 versus 48 versus 78%). There were no significant differences between dolasetron and ondansetron. There was no important methylene blue contamination, and little use of rescue metoclopramide. There were no important adverse events. CONCLUSIONS: Prophylactic oral dolasetron and ondansetron were effective in reducing postoperative nausea and vomiting in children.     

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.     

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.     

Importance of right subcostal incisions in patients undergoing TRAM flap breast reconstruction

The presence of a preexisting subcostal incision alters the approach to breast reconstruction and is thought to predispose to donor site skin complications and flap loss. The purpose of this study was to determine whether the presence of a subcostal scar affects breast or donor site morbidity adversely after transverse rectus abdominis musculocutaneous (TRAM) flap breast reconstruction. Twenty-six patients with a right subcostal incision (group A) underwent TRAM flap breast reconstruction (13 immediate, 13 delayed). The average age was 51 years, and the patients had an average body mass index of 25.3. There were 15 right, 10 left, and 1 bilateral reconstruction (4 free flaps, 22 pedicled). Outcome measures were compared with 126 age- and risk-matched patients (group B) who underwent TRAM flap reconstruction without any preexisting abdominal scar. The average age in group B was 46.7 years, and the patients had an average body mass index of 24.8. The average length of stay in group A was 5.9 days, compared with 4.8 days in group B ( < 0.05). There were no significant differences in breast-related complications. Donor site complications were higher in group A, with abdominal wall skin necrosis being significantly higher in patients with a subcostal incision (25%) compared with those patients without abdominal wall scars (5%; = 0.02). Multivariate analysis revealed a 6.5-fold increase in donor site complications in patients with a subcostal incision and a smoking history ( < 0.05). When adjusted for radiation treatment, the increased incidence in donor site complication rate was only marginally significant ( = 0.08). TRAM flap breast reconstruction in patients with preexisting right subcostal scars is effective with certain technical modifications; however, there is a slight predisposition to increased abdominal wall complications. Smoking influenced outcome further in patients with a subcostal incision, stressing the importance of proper patient selection.     

Low-dose droperidol versus standard-dose droperidol for prevention of postoperative vomiting after pediatric strabismus surgery

STUDY OBJECTIVE: To determine whether a low dose of droperidol is as effective as a high dose in preventing vomiting after pediatric strabismus surgery. DESIGN: Randomized, double-blind study. SETTING: Operating room and recovery room at a university medical center. PATIENTS: One hundred children undergoing strabismus procedures. INTERVENTIONS: Patients were divided randomly into three groups and received either droperidol 75 microgram/kg, droperidol 20 microgram/kg, or saline. MEASUREMENTS AND MAIN RESULTS: Vomiting was assessed in all groups, as was time to discharge and ability to perform a satisfactory postoperative eye examination. Children who received droperidol vomited less frequently than those who did not (p = 0.0521). There was no difference in the frequency of vomiting between the two groups that received droperidol. CONCLUSION: Droperidol 20 microgram/kg is as effective as droperidol 75 microgram/kg in preventing vomiting after pediatric strabismus surgery. Because higher doses of droperidol may sedate some patients, the lowest effective dose should be used. In this study, however, there was no statistically significant difference with regard to length of recovery room stay.     

Intravenous dolasetron and ondansetron in prevention of postoperative nausea and vomiting: a multicenter, double-blind, placebo-controlled study

Background: Intravenous dolasetron mesilate has shown efficacy in the prevention of postoperative nausea and vomiting (PONV) when administered as a single dose prior to emergence from anesthesia. This trial compared intravenous dolasetron and ondansetron for the prevention of PONV when administered at induction of anesthesia.
Methods: This double-blind, placebo-controlled, multicenter trial randomized patients to one of four single IV treatments: placebo, 25 or 50 mg dolasetron, or 4 mg ondansetron. Efficacy was measured by complete response (0 emetic episodes and no rescue medication), nausea severity and patient satisfaction as measured on a visual analog scale (VAS), investigator's rating of nausea severity, and total response (complete response with no nausea [≤ mm VAS]).
Results: 514 patients at 24 sites were evaluated for efficacy. The 50 mg dolasetron and 4 mg ondansetron doses were statistically equivalent, and superior to placebo, for all efficacy measures. Complete response rates were 49%, 51%, 71% and 64% for placebo, 25 and 50 mg dolasetron, and ondansetron, respectively. Dolasetron 50 mg was statistically superior to 25 mg dolasetron for complete response, total response, VAS maximum nausea, time to first emetic episode, and patient satisfaction. The majority of adverse events were of mild-to-moderate intensity. Headache was the most frequently reported treatment-related adverse event with a 3%-5% incidence across treatments.
Conclusion: When given at induction of anesthesia, 50 mg intravenous dolasetron is equivalent to 4 mg ondansetron and superior to 25 mg dolasetron and placebo for the prevention of PONV. All treatments were safely administered and well tolerated.     

Single-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind phase III trial in patients undergoing open abdominal surgery

Background: The neurokinin₁ antagonist aprepitant is effective for preventionof chemotherapy-induced nausea and vomiting. We compared aprepitantwith ondansetron for prevention of postoperative nausea andvomiting. Methods: Nine hundred and twenty-two patients receiving general anaesthesiafor major abdominal surgery were assigned to receive a singlepreoperative dose of oral aprepitant 40 mg, oral aprepitant125 mg, or i.v. ondansetron 4 mg in a randomized, double-blindtrial. Vomiting episodes, use of rescue therapy, and nauseaseverity (verbal rating scale) were documented for 48 h aftersurgery. Primary efficacy endpoints were complete response (novomiting and no use of rescue therapy) 0–24 h after surgeryand no vomiting 0–24 h after surgery. The secondary endpointwas no vomiting 0–48 h after surgery. Results: Aprepitant at both doses was non-inferior to ondansetron forcomplete response 0–24 h after surgery (64% for aprepitant40 mg, 63% for aprepitant 125 mg, and 55% for ondansetron, lowerbound of 1-sided 95% CI > 0.65), superior to ondansetronfor no vomiting 0–24 h after surgery (84% for aprepitant40 mg, 86% for aprepitant 125 mg, and 71% for ondansetron; P< 0.001), and superior for no vomiting 0–48 h aftersurgery (82% for aprepitant, 40 mg, 85% for aprepitant, 125mg, and 66% for ondansetron; P < 0.001). The distributionof peak nausea scores was lower in both aprepitant groups vsondansetron (P < 0.05). Conclusions: Aprepitant was non-inferior to ondansetron in achieving completeresponse for 24 h after surgery. Aprepitant was significantlymore effective than ondansetron for preventing vomiting at 24and 48 h after surgery, and in reducing nausea severity in thefirst 48 h after surgery. Aprepitant was generally well tolerated.     

A comparison of the costs and efficacy of ondansetron and dolasetron in the prophylaxis of postoperative vomiting in pediatric patients undergoing ambulatory surgery

Postoperative vomiting (POV) after ambulatory surgery remains a major problem. We designed this study to determine the smallest dose of dolasetron equivalent to the Food and Drug Administration approved dose of ondansetron 100 micro g/kg IV, for the prophylaxis of POV in children undergoing surgery. In this double-blinded controlled study, 204 healthy ASA I-II children aged 2-12 yr, undergoing superficial ambulatory (day-case) surgery, were randomized to receive either ondansetron 100 micro g/kg IV, or dolasetron 45, 175, 350, or 700 micro g/kg IV during a standardized perioperative regimen. The primary end-point was the incidence of complete response, defined as the absence of POV symptoms. Costs were calculated from the perspective of the hospital using a previously described model. The incidence of early (0-6 h) and 24-h emesis was more frequent in the dolasetron 45 micro g/kg group compared with the dolasetron 350 and 700 micro g/kg groups and with the ondansetron group. Repeated POV occurred more often when dolasetron was used in a dose <350 micro g/kg. There were no significant differences in emesis rates between the dolasetron 175, 350, and 700 micro g/kg groups or between these groups and the ondansetron 100 micro g/kg group. The smallest dose of dolasetron with acceptable equivalent efficacy and patient satisfaction scores to ondansetron 100 micro g/kg was 350 micro g/kg. Institutional costs for managing POV were less with dolasetron 350 micro g/kg than with ondansetron. IMPLICATIONS: This randomized double-blinded dose-ranging study concluded that dolasetron, 350 micro g/kg IV, was the smallest dose that provided acceptable equivalent efficacy and patient satisfaction scores to ondansetron, 100 micro g/kg IV, for the prophylaxis of postoperative vomiting in children undergoing outpatient surgery. However, with this dose, the costs to the institution for managing postoperative vomiting were less.     

Ramosetron for preventing postoperative nausea and vomiting in women undergoing gynecological surgery

In a prospective, randomized, double-blinded, placebo-controlled trial, we evaluated the efficacy of ramosetron at three different doses (0.15, 0.3, and 0.6 mg) for the prevention of postoperative nausea and vomiting (PONV) after gynecological surgery. One hundred twenty women, ASA physical status I or II, aged 21-63 yr, received IV either placebo or ramosetron 0.15, 0.3, or 0.6 mg (n = 30 of each) at the completion of surgery. A standard general anesthetic technique and postoperative analgesia were used. A complete response, defined as no PONV and no need for another rescue antiemetic, during 0-3 h after anesthesia occurred in 40%, 47%, 87%, and 90% of patients who had received placebo and ramosetron 0.15, 0.3, and 0.6 mg, respectively. Corresponding results during 3-24 h after anesthesia were 43%, 50%, 87%, and 90%, and 24-48 h after anesthesia were 50%, 53%, 90%, and 93% (P < 0.05). Patients who had received ramosetron 0.3 or 0.6 mg were satisfied compared with those who had received placebo (P < 0.05). There were no serious clinical adverse events caused by the study drug in any of the groups. In conclusion, ramosetron 0.3 mg is an effective antiemetic for preventing PONV during 0-48 h after anesthesia in female patients undergoing gynecological surgery. Increasing the dose to 0.6 mg provided no further benefit. IMPLICATIONS: This randomized, double-blinded, placebo-controlled trial in 120 women found the effective dose of ramosetron for preventing postoperative nausea and vomiting after gynecological surgery to be 0.3 mg.