Intravenous dolasetron mesilate ameliorates postoperative nausea and vomiting

Purpose

To compare the efficacy, safety, and tolerability of dolasetron mesilate with placebo for the treatment of postoperative nausea and vomiting (PONV).

Methods

In a randomized, multicentre, double-blind, placebo-controlled study 337 adult patients undergoing surgery with general anaesthesia received one of four single, doses of dolasetron mesilateiv (12.5, 25, 50. or 100 mg) or placebo. Study medication was administered postoperatively when the patient reported nausea lasting 10 mm or when one emetic episode occurred within two hours of the patient’s arrival in the recovery room. Efficacy was assessed by the investigators over the 24-hr study penod by recording the number and timing of emetic episodes, the severity of nausea, the timing of administration of escape antiemetic medications. and patients’ and investigators’ satisfaction with antiemetic therapy.

Results

The study sample was predominately women, and the surgical procedures were primarily gynaeco logical. All dolasetron mesilate doses produced higher complete response rates than placebo (P< 0.05). Only approximately one-third of dolasetron patients required escape antiemetic medication compared with more than 50% of patients in the placebo group. Both patient and physician satisfaction with dolasetron treatment was high. The most common adverse event was mild or moderate headache for both placebo-treated patients and dolasetron-treated patients. Clinical laboratory results were unremarkable.

Conclusion

Single doses of dolasetron mesilateiv, given after the first episode of PONV were both effective and safe in this adult patient population.     

Prophylactic oral dolasetron mesylate reduces nausea and vomiting after abdominal hysterectomy

Purpose

The incidence of postoperative nausea and vomiting (PONV) varies from 50% to 75% after gynaecological surgery under general anaesthesia. This study evaluates the dose-response relationships, safety, and efficacy of the new 5-HT₃ antagonist, dolasetron mesylate, in the prevention of PONV in women undergoing total abdominal hysterectomy (TAH).

Methods

Three hundred and seventy four women scheduled for TAH under general anaesthesia were studied at 13 Canadian centres. Patients received in a randomized, double-Wind manner 25, 50, 100, or 200 mg dolasetron or placebo po one to two hours before induction of anaesthesia. The anesthetic protocol was standardized. Efficacy was evaluated for 24 hr after surgery by companng the number of emetic episodes, administration of rescue medication, seventy of nausea, and patient satisfaction.

Results

Analysis of complete response (no emetic episodes and no rescue for 24 hr) revealed a linear doseresponse relationship across dolasetron groups (P < 0.002). Dolasetron 100 mg (P < 0.003) and 200 mg (P < 0.01) were superior to placebo. The percentage of patents with no emetic episodes increased from 29.3% (placebo) to 54.1 % (100 mg). Subgroup analysis revealed ASA status (I > II), previous history of PONV, previous history of motion sickness, and total morphine dose (> 55 mg associated with less PONV than < 55 mg) influenced the incidence of emetic symptoms, but did not alter the results of the primary analysis.

Conclusion

Prophylactic dolasetron (100 mg and 200 mg) reduces the incidence of PONV in patients having total abdominal hysterectomy.     

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.     

枢复宁预防全麻腹部手术后恶心和呕吐的临床研究

全麻患者术后常易发生恶心、呕吐，枢复宁有抗呕吐作用。随机选择１００例腹部外科手术患者，分为枢复宁组（４ｍｇ，ｎ＝５０）和安慰剂组（生理盐水，ｎ＝５０），诱导前静注枢复宁或安慰剂，注速１分钟，双盲法观察术后２４小时抗恶心、呕吐效果及副作用。结果表明，用药组恶心、呕吐发生率（１８％，０）明显低于安慰剂组（５０％，４０％）（Ｐ＜０．０１），两组患者的平均动脉压、经皮血氧饱和度，呼吸频率和心率，血液成分，肝、肾功能无明显改变。因此，枢复宁适用于腹部外科患者术后恶心、呕吐的防治。     

电针联合托烷司琼预防全子宫切除术后恶心呕吐的效果

目的 观察电针联合托烷司琼治疗全子宫切除患者术后恶心呕吐(PONV)的效果.方法 60例择期行妇科经腹全子宫切除患者,随机均分为单纯药物组(M组)和针药联合组(A组).两组术前均静脉推注托烷司琼5 mg.A组在术后5、23、47 h取双侧内关、足三里、上巨虚等穴位针刺.记录两组患者术后48 h内的PONV发生情况、首次排气时间,以及麻醉前、术毕即刻、术后24、48 h血浆胃动素(MTL)和血清胃泌素(GAS)浓度变化.结果 术后24 hM组PONV发生率明显高于A组(P＜0.05).A组首次排气时间明显短于M组(P＜0.01).术后24、48 hA组MTL明显低于M组,GAS明显高于M组(P＜0.05).结论 针刺联合托烷司琼能有效降低PONV发生率,改善胃肠功能.     

Management of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy

The common and distressing complications of postoperative nausea and vomiting (PONV) are the main concern of 40–70% of patients undergoing laparoscopic cholecystectomy (LC). The first step in preventing PONV after LC is to reduce the risk factors involving patient characteristics, surgical procedure, anesthetic technique, and postoperative care. Particularly, the use of propofol-based anesthesia can reduce the incidence of PONV after LC. Second, prophylactic antiemetics including antihistamines (dimenhydrinate), phenothiazines (perphenazine), butyrophenones (droperidol), benzamides (metoclopramide), dexamethasone, and serotonin receptor antagonists (ondansetron, granisetron, tropisetron, dolasetron, and ramosetron) are available for preventing PONV after LC. Third, antiemetic therapy combined with a serotonin receptor antagonist (ondansetron, granisetron) and droperidol or dexamethasone is highly effective in the prevention of PONV after LC. Fourth, acupressure at the P6 point is a nonpharmacologic technique that is as effective as ondansetron for preventing PONV after LC. Knowledge regarding the risk factors for PONV and antiemetics is needed for the management of PONV after LC.     

Prevention of post-operative nausea and vomiting. Randomised comparison of dolasetron versus dolasetron plus dexamethasone

BACKGROUND: Postoperative nausea and vomiting (PONV) are frequent complications after operations.The aim of this study was to assess the efficacy of combined dolasetron plus dexamethasone versus dolasetron alone with respect to the incidence and severity of emetic symptoms and patients satisfaction. METHODS: In a prospective, randomised, double-blind study, 150 patients scheduled for hysterectomy or breast surgery were allocated to one of the following two groups: group A received 50 mg dolasetron orally and group B 50 mg dolasetron orally plus 8 mg dexamethasone intravenously.The follow-up was for 24 h after surgery. RESULTS: In group A PONV was significantly more frequent (28%) compared to group B (12.0%).The incidence of vomiting was significantly lower in patients receiving dolasetron plus dexamethasone (0%) in comparison to patients receiving dolasetron (8.0%). Furthermore,patients satisfaction was significantly higher in group B compared to group A. About 6 or 7 patients need to be treated with additional dexamethasone instead of a placebo for one patient to benefit from this intervention (i.e. to stay free from PONV) who otherwise would have suffered from PONV. CONCLUSIONS: Combining oral dolasetron with intravenous dexamethasone further improves the antiemetic efficacy of dolasetron. With a number-needed-to-treat of about 6 the additional benefit might be considered clinically relevant.     

Oral ondansetron,tropisetron or metoclopramide to prevent postoperative nausea and vomiting: a comparison in high-risk patients undergoing thyroid or parathyroid surgery

BACKGROUND: Oral antiemetic prophylaxis may be a practical alternative to intravenous administration. Intravenous ondansetron and tropisetron prevent postoperative nausea and vomiting (PONV) at least as efficiently as traditional antiemetics, droperidol and metoclopramide. We tested the hypothesis that the incidence of PONV after oral ondansetron or tropisetron prophylaxis is lower compared with metoclopramide among high-risk patients. METHODS: In a prospective, double-blind study we studied 179 high-risk patients who received either ondansetron 16 mg, tropisetron 5 mg, or metoclopramide 10 mg orally 1 h before the operation. A standard general anesthetic technique and postoperative analgesia were used. The incidence of PONV and the need for rescue antiemetic medication was recorded for 24 h. RESULTS: In the postanesthesia care unit, the incidence of PONV was lower after premedication with tropisetron compared with ondansetron and metoclopramide (15%, 32% and 39%, respectively). The incidence of PONV during 0-24 h was the same in each group (68%, 58% and 75% in the ondansetron, tropisetron and metoclopramide group, respectively), but the incidence of vomiting was significantly lower after ondansetron (34%) and tropisetron (22%) prophylaxis compared with metoclopramide (53%). The need for additional antiemetics was significantly lower after tropisetron prophylaxis compared with metoclopramide. Patient satisfaction was significantly higher after tropisetron than after metoclopramide. CONCLUSIONS: In the initial period, the incidence of PONV was lower after premedication with oral tropisetron than after ondansetron or metoclopramide. Considering the entire 24-h postoperative period, the incidence of PONV was the same after all three premedications, but the incidence of vomiting was lower after oral ondansetron and tropisetron than after metoclopramide.     

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.      

星状神经节阻滞对腹腔镜全子宫切除术患者术后睡眠质量和恶心呕吐的影响

目的 观察超声引导下右侧星状神经节阻滞（SGB）对腹腔镜全子宫切除术患者术后睡眠质量和恶心呕吐（PONV）的影响。
方法 选择择期行腹腔镜全子宫切除术患者98例,年龄42～74岁,BMI 19～25 kg/m ²,ASAⅠ或Ⅱ级。采用随机数字表法分为两组：全身麻醉联合SGB组（S组）和全身麻醉组（GA组）,每组49例。S组于麻醉诱导前在超声引导下行右侧SGB,注入 0.2%罗哌卡因5 ml,GA组不行SGB。两组采用相同的全身麻醉方法和麻醉药物。记录术前1 d、手术当日、术后1 d的匹兹堡睡眠质量指数（PSQI）。记录术后24 h PONV分级和止吐药补救情况。记录术后24 h活动时VAS疼痛评分、镇痛药补救情况、术后首次下床活动时间和术后住院时间。记录局麻药中毒、全脊髓麻醉、气胸、臂丛神经阻滞等SGB相关并发症发生情况。
结果 与GA组比较,S组手术当日、术后1 d PSQI评分、POSD发生率明显降低（P＜0.05）,PONV 0级、1级发生率明显升高,PONV 2级、3级、4级发生率、止吐药补救率明显降低（P＜0.05）,术后24 h活动时VAS疼痛评分明显降低（P＜0.05）,术后首次下床活动时间明显缩短（P＜0.05）。两组补救镇痛情况、术后住院时间差异无统计学意义。S组无一例出现局麻药中毒、全脊髓麻醉、气胸、臂丛神经阻滞等SGB相关并发症。
结论 右侧星状神经节阻滞可有效改善腹腔镜全子宫切除术患者的术后睡眠质量,降低术后恶心呕吐的发生率及严重程度,减轻术后疼痛。     

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.     

Timing of administration of dolasetron affects dose necessary to prevent postoperative nausea and vomiting

STUDY OBJECTIVE: To determine if the timing of administration affects the dose of dolasetron necessary to prevent postoperative nausea and vomiting (PONV). DESIGN: Pooled data from 8 randomized, multicenter, double-blind, placebo-controlled studies with common endpoints. SETTING: University hospital. PATIENTS: A total of 4,587 ASA physical status I, II, and III patients, including 4,124 females undergoing primarily gynecologic procedures and 463 males undergoing various procedures (i.e., thyroidectomy or orthopedic, ophthalmologic, urologic, ENT, or laparoscopic surgery). INTERVENTIONS: Balanced general anesthesia was used during all procedures. Patients received a dose of dolasetron either for prevention of PONV (25 or 50 mg IV at induction; 25, 50, 100, or 200 mg orally 1 to 2 hours pre-induction; or 12.5, 25, 50, or 100 mg IV at end of anesthesia) or for treatment of PONV (12.5, 25, 50, or 100 mg IV). One PONV prevention study had an ondansetron (comparator) group. MEASUREMENTS: Outcome measures over a 24-hour study period included complete response (defined as no vomiting/retching and no need for rescue medication), percentage of patients without nausea [defined as nausea visual analog scale (VAS) score < 5 mm], and maximum nausea according to VAS score. MAIN RESULTS: A 12.5-mg IV dose of dolasetron resulted in a complete response rate that was statistically significantly higher than placebo and comparable to higher dolasetron doses (25 mg to 100 mg IV) when administered either near the end of anesthesia for prevention of PONV or at the onset of symptoms for treatment of PONV. In contrast, when administered at induction of anesthesia, a statistically significant treatment response was observed with dolasetron 50 mg IV, but not at a lower dose. CONCLUSIONS: When dosed near the end of anesthesia, a 12.5 mg IV dose of dolasetron was comparable to higher doses administered at or before induction of anesthesia.     

Randomized, double-blind trial of dolasetron versus droperidol for prophylaxis of postoperative nausea and vomiting in patients undergoing TRAM flap breast reconstruction surgery

Clinical observation indicates that patients undergoing transverse rectus abdominus musculocutaneous (TRAM) flap breast reconstruction surgery frequently experience postoperative nausea and/or vomiting (PONV). No controlled trials have evaluated the role of pharmacologic prophylaxis of PONV in this population. A prospective randomized, double-blinded, active-controlled trial comparing intraoperative intravenous droperidol 1 mg with dolasetron 50 mg was conducted. Seventy-one patients were included in the intention-to-treat analysis. The incidence of the primary end point of PONV within 24 hours after surgery was 81.8% versus 78.9% for droperidol and dolasetron, respectively (p = 0.8). No significant differences were detected in the time to onset of PONV, incidence of severe nausea or emesis, or incidence of emesis alone. Time to rescue antiemetic use was longer in the droperidol group (7.1 vs. 1.3 hours, p = 0.002). Adverse effects were similar between the two groups. No PONV-related complications occurred during the trial period. The incidence of PONV in TRAM flap breast reconstruction surgery patients remains high despite prophylactic intraoperative antiemetic administration.     

右美托咪定用于预防腹腔镜胆囊切除术后恶心呕吐的效果

目的观察右美托咪定预防腹腔镜胆囊切除术后恶心呕吐的效果。方法选择择期行腹腔镜胆囊切除术的患者70例,男17例,女53例,年龄20~65岁,ASAⅠ或Ⅱ级。随机分为两组:右美托咪定组(R组)和地塞米松组(D组),每组35例。R组于麻醉诱导前静脉注射右美托咪定,背景剂量为0.5μg/kg,10min内注射完毕,后以0.5μg·kg~(-1)·h~(-1)维持输注。D组给予地塞米松8mg静脉注射。观察患者入室(T_1)、插管前(T_2)、插管后5min(T_3)、手术开始后5 min(T_4)、手术开始后30min(T_5)、缝皮时(T_6)、拔管后5min(T_7)的血压和心率。记录术中七氟醚的吸入浓度、停七氟醚至拔管的时间、手术时间及麻醉时间。观察患者8、24、48h内有无发生恶心呕吐。结果两组患者术后8、24、48h的恶心发生率和呕吐发生率差异无统计学意义。T2~T7时R组HR明显低于D组(P0.05),两组间MAP差异无统计学意义。结论与静脉注射地塞米松8mg比较,静脉注射右美托咪定负荷量0.5μg/kg(10min),维持量0.5μg·kg~(-1)·h~(-1),对减少腹腔镜胆囊术后恶心呕吐的发生有相同的效果。