Eberhart L H, Holzrichter P, Roscher R
Klinik für Anaesthesie der Universität Ulm.
Anaesthesist. 1996 Mar;45(3):259-67. doi: 10.1007/s001010050262.
In a prospective double-blind trial, transdermal scopolamine (TS) was compared to placebo (P) in the prevention of postoperative nausea and vomiting (PONV) within a 48-h interval. After stratification for gender and surgical procedure, patients were randomly chosen to receive either TS or placebo.
Of 304 surgical and gynaecological patients included in this study, the data of 263 patients were evaluated (48 thyroidectomies, 15 open, and 36 laparoscopic cholecystectomies, 41 open, and 36 laparoscopic hernia repairs, 37 hysterectomies, and 50 gynaecological laparoscopies). The two groups were comparable with regard to biometrical data and duration of anaesthesia and surgery. Although anaesthesia was not standardized, there was no difference in anaesthesia techniques, drug dosage or perioperative management. Patients were evaluated once preoperatively and 2, 6, 10, 24, and 48 h postoperatively using a 100-mm visual analogue scale (VAS) for "nausea", "pain", "dry mouth", "sedation", and "blurred vision". Episodes of vomiting or retching and the need for additional antimetics (0.03 mg.kg-1 metoclopramide i.v., followed by 1 mg.kg-1 dimenhydrinat i.v., if necessary) were recorded.
TS significantly reduced the incidence of postoperative vomiting within the first 48 h postoperatively [TS: 47 patients (36.2%) with 125 cumulative episodes vs P: 70 patients (52.6%) with 209 cumulative episodes]. Analysing the five observation intervals seperately, this difference could only be demonstrated 0-2 h and 6-10 h postoperatively. In patients suffering from emetic sequelae, TS did not reduce the frequency of vomiting significantly (mean frequency: TS: 2.7 vs P: 3.0). TS also had no significant effect on the requirement of additional antiemetics [TS:. 81 times in 46 (35.7%) patients vs P: 116 times in 58 (44.3%) patients]. Nausea as rated by the VAS was not significantly different between the two groups at any time during the postoperative observation. No relevant side-effects occurred, although there was a trend toward higher ratings of "dry mouth" in the TS group, reaching statistical significance 10 h after operation.
The routine administration of TS for gynaecological and surgical patients cannot be recommended because of the lack of effect on postoperative nausea and only marginal benefit concerning postoperative vomiting.
在一项前瞻性双盲试验中，比较了透皮东莨菪碱（TS）与安慰剂（P）在48小时内预防术后恶心和呕吐（PONV）的效果。在按性别和手术方式分层后，随机选择患者接受TS或安慰剂。
本研究纳入304例外科和妇科患者，对其中263例患者的数据进行了评估（48例甲状腺切除术、15例开放性和36例腹腔镜胆囊切除术、41例开放性和36例腹腔镜疝修补术、37例子宫切除术以及50例妇科腹腔镜手术）。两组在生物统计学数据、麻醉及手术持续时间方面具有可比性。尽管麻醉未标准化，但麻醉技术、药物剂量或围手术期管理并无差异。术前及术后2、6、10、24和48小时，使用100毫米视觉模拟量表（VAS）对患者的“恶心”“疼痛”“口干”“镇静”及“视力模糊”情况进行评估。记录呕吐或干呕发作次数以及额外使用止吐药的需求（静脉注射0.03mg/kg甲氧氯普胺，必要时随后静脉注射1mg/kg茶苯海明）。
TS显著降低了术后48小时内的呕吐发生率[TS组：47例患者（36.2%），累计发作125次；P组：70例患者（52.6%），累计发作209次]。分别分析五个观察时间段，仅在术后0 - 2小时和6 - 10小时显示出这种差异。在有呕吐后遗症的患者中，TS未显著降低呕吐频率（平均频率：TS组为2.7次，P组为3.0次）。TS对额外使用止吐药的需求也无显著影响[TS组：46例（35.7%）患者使用81次，P组：58例（44.3%）患者使用116次]。术后观察期间，两组在任何时间点通过VAS评估的恶心程度均无显著差异。未出现相关副作用，尽管TS组“口干”评分有升高趋势，在术后10小时达到统计学显著性。
由于TS对术后恶心无作用，对术后呕吐仅有微小益处，因此不建议对妇科和外科患者常规使用TS。
