Bellissant Eric, Estèbe Jean-Pierre, Sébille Véronique, Ecoffey Claude
Centre d'Investigation Clinique INSERM 0203, Unité de Pharmacologie Clinique, Hôpital de Pontchaillou, Université de Rennes 1, 35033 Rennes, France.
Fundam Clin Pharmacol. 2004 Dec;18(6):709-14. doi: 10.1111/j.1472-8206.2004.00290.x.
Sustained-release morphine sulfate (SRMS) is a painkiller used in oncology. The purpose of our study was to assess its efficacy on postoperative morphine requirements in elective spine surgery. This was a placebo-controlled, randomized, double-blind study. Adults scheduled for spine surgery under general anesthesia were orally administered SRMS (30 mg) or a placebo 2 h before surgery. Primary endpoint was postoperative cumulated morphine consumption through patient-controlled analgesia (PCA) during the 12 h following extubation. Statistical analysis was performed using a sequential method, the triangular test. The study was stopped after the sixth analysis (51 patients had been included; placebo: 26, SRMS: 25). Age, weight, sex ratio, type of surgery, intra-operative sufentanil consumption, anesthesia duration and time to extubation were similar in the two groups. Morphine consumption through PCA during the 12 h following extubation was significantly lower in the SRMS group (mean +/- SD: 10.5 +/- 7.6 mg) compared with placebo group (15.6 +/- 6.0 mg, P = 0.016, sequential analysis). Corresponding unbiased median estimates were 10.6 and 15.8 mg in SRMS and placebo groups, respectively. Morphine consumption through PCA during the 24 h following extubation was also significantly lower in the SRMS group (15.9 +/- 12.7 mg) compared with the placebo group (23.8 +/- 10.9 mg, P = 0.032). Vigilance, nausea and respiratory rate 3 and 6 h after extubation were similar in the two groups. A preoperative oral administration of SRMS (30 mg) induces a 33% reduction of postoperative morphine requirements in patients scheduled for spine surgery without inducing side effects.
硫酸吗啡缓释片(SRMS)是一种用于肿瘤学的止痛药。我们研究的目的是评估其对择期脊柱手术术后吗啡需求量的疗效。这是一项安慰剂对照、随机、双盲研究。计划在全身麻醉下进行脊柱手术的成年人在手术前2小时口服SRMS(30毫克)或安慰剂。主要终点是拔管后12小时内通过患者自控镇痛(PCA)的术后累积吗啡消耗量。使用序贯方法三角检验进行统计分析。在第六次分析后(纳入了51名患者;安慰剂组:26名,SRMS组:25名)研究停止。两组在年龄、体重、性别比、手术类型、术中舒芬太尼消耗量、麻醉持续时间和拔管时间方面相似。与安慰剂组(15.6±6.0毫克,P = 0.016,序贯分析)相比,SRMS组拔管后12小时内通过PCA的吗啡消耗量显著更低(平均值±标准差:10.5±7.6毫克)。SRMS组和安慰剂组相应的无偏中位数估计分别为10.6毫克和15.8毫克。与安慰剂组(23.8±10.9毫克,P = 0.032)相比,SRMS组拔管后24小时内通过PCA的吗啡消耗量也显著更低(15.9±12.7毫克)。两组在拔管后3小时和6小时的警觉性、恶心和呼吸频率相似。术前口服SRMS(30毫克)可使计划进行脊柱手术的患者术后吗啡需求量降低33%,且不产生副作用。