Eberhart L H, Seeling W, Morin A M, Vogt N, Georgieff M
Klinik für Anästhesiologie Universität Ulm.
Anasthesiol Intensivmed Notfallmed Schmerzther. 2001 May;36(5):290-5. doi: 10.1055/s-2001-14473.
Droperidol and dimenhydrinate are inexpensive antiemetic drugs. Droperidol, especially, has been studied extensively in the past, but there are no studies that used the combination of both drugs for prevention of postoperative nausea and vomiting (PONV). Thus, the aim of this randomised controlled and double-blinded study was to evaluate the antiemetic efficacy and the side effects of such a combination therapy.
240 inpatients undergoing ENT surgery under general anaesthesia were randomised to receive one of four antiemetic regimes: placebo, dimenhydrinate (1 mg x kg-1), droperidol (15 micrograms x kg-1), or the combination of both drugs (droperidol 15 micrograms x kg-1 + dimenhydrinate 1 mg x kg-1) was administered after induction of anaesthesia and repeated 6 hours after the first administration. For general anaesthesia a standardised technique including benzodiazepine premedication, propofol, desflurane in N2O/O2, vecuronium, and a continuous infusion of remifentanil was used. Postoperative analgesia and antiemetic rescue medication were standardised. Episodes of vomiting, retching, nausea, and the need for additional antiemetics were recorded for 24 hours. The main goal of the study was to increase the number of patients who were completely free from PONV (chi 2-test with Fisher-Yates' correction). Furthermore, the severity of PONV was analysed using a standardised scoring algorithm.
Data of 227 patients could be analysed. The incidence of patients who suffered from PONV was 41.3% (95%-confidence interval: 29-55%) in the placebo-group. Dimenhydrinate alone reduced PONV to 34.5% (95%-CI: 22-48%). This marginal effect and the effect of droperidol (PONV: 26.4% (95%-CI: 15-40%)) could not be proven statistically, since the power of the study was too small. The combination of both drugs decreased PONV to 19.6% (95%-CI: 10-32%) and also reduced the severity of the symptoms to a clinically acceptable level.
Dimenhydrinate failed to reduce the incidence and severity of PONV. The efficiency of droperidol given alone was within the ranges previously known from metaanalytic data. The combination of both drugs showed a moderate synergistic effect.
氟哌利多和茶苯海明是廉价的止吐药物。尤其是氟哌利多,过去已进行了广泛研究,但尚无关于联合使用这两种药物预防术后恶心和呕吐(PONV)的研究。因此,这项随机对照双盲研究的目的是评估这种联合疗法的止吐效果和副作用。
240例接受全身麻醉的耳鼻喉科手术住院患者被随机分为接受四种止吐方案之一:安慰剂、茶苯海明(1mg/kg)、氟哌利多(15μg/kg)或两种药物联合使用(氟哌利多15μg/kg + 茶苯海明1mg/kg),在麻醉诱导后给药,并在首次给药后6小时重复给药。全身麻醉采用标准化技术,包括苯二氮䓬类药物术前用药、丙泊酚、N2O/O2中的地氟烷、维库溴铵以及瑞芬太尼持续输注。术后镇痛和止吐急救药物标准化。记录24小时内的呕吐、干呕、恶心发作次数以及使用额外止吐药的需求。该研究的主要目标是增加完全无PONV的患者数量(采用Fisher-Yates校正的卡方检验)。此外,使用标准化评分算法分析PONV的严重程度。
227例患者的数据可进行分析。安慰剂组中发生PONV的患者发生率为41.3%(95%置信区间:29 - 55%)。单独使用茶苯海明将PONV降低至34.5%(95%CI:22 - 48%)。由于研究效能过小,这种微小效应以及氟哌利多的效应(PONV:26.4%(95%CI:15 - 40%))无法得到统计学证实。两种药物联合使用将PONV降低至19.6%(95%CI:10 - 32%),并且还将症状严重程度降低至临床可接受水平。
茶苯海明未能降低PONV的发生率和严重程度。单独使用氟哌利多的疗效在先前荟萃分析数据已知的范围内。两种药物联合使用显示出适度的协同效应。