Blobner M, Mirakhur R K, Wierda J M, Wright P M, Olkkola K T, Debaene B, Pendeville P, Engbaek J, Rietbergen H, Sparr H J
Department of Anaesthesia, Technische Universität München, Klinikum r. d. Isar, Munich, Germany.
Br J Anaesth. 2000 Nov;85(5):724-31. doi: 10.1093/bja/85.5.724.
The purpose of this nine-centre study in 602 patients was to show that the frequency of acceptable intubating conditions after rapacuronium 2.0 or 2.5 mg kg-1 is not more than 10% lower than the frequency after succinylcholine 1.0 mg kg-1 during rapid-sequence induction of anaesthesia with fentanyl 1-2 micrograms kg-1 and thiopental 2-7 mg kg-1. Laryngoscopy and intubation were carried out 60 s after administration of muscle relaxant by an anaesthetist blinded to its identity. Intubating conditions were clinically acceptable (excellent or good) in 91.8% of patients given succinylcholine and in 84.1 and 87.6% of patients given rapacuronium 2.0 and 2.5 mg kg-1 respectively. With respect to the percentage of clinically acceptable intubating conditions, the estimated difference (and the upper limit of the one-sided 97.5% confidence interval) between succinylcholine and rapacuronium 2.0 mg kg-1 was 7.8 (14.4)% and between succinylcholine and rapacuronium 2.5 mg kg-1 it was 4.0 (10.2)%. For both comparisons, the upper limit of the one-sided confidence interval exceeded the predefined 10% difference. Hence, it could not be demonstrated that the intubating conditions with either of the two doses of rapacuronium were not inferior to those with succinylcholine 1.0 mg kg-1. The increase in heart rate was significantly greater during the first 5 min in the rapacuronium groups, but the arterial pressure increased significantly only in the succinylcholine group (P < 0.001). Respiratory side-effects were observed in 4.0, 13.5 and 18.5% of patients after succinylcholine and rapacuronium 2.0 and 2.5 mg kg-1 respectively (P < 0.05). As the non-inferiority of intubating conditions after rapacuronium 2.0 and 2.5 mg kg-1 could not be proven, succinylcholine should be considered the neuromuscular blocking agent that provides better intubating conditions for rapid-sequence induction.
这项针对602例患者的九中心研究旨在表明,在使用1 - 2微克/千克芬太尼和2 - 7毫克/千克硫喷妥钠进行快速顺序诱导麻醉时,2.0或2.5毫克/千克罗库溴铵后可接受的插管条件发生率,相比1.0毫克/千克琥珀胆碱后,降低幅度不超过10%。在给予肌肉松弛剂60秒后,由对其身份不知情的麻醉医生进行喉镜检查和插管操作。给予琥珀胆碱的患者中,91.8%的患者插管条件在临床上是可接受的(优或良);给予2.0毫克/千克和2.5毫克/千克罗库溴铵的患者中,这一比例分别为84.1%和87.6%。就临床上可接受的插管条件百分比而言,琥珀胆碱与2.0毫克/千克罗库溴铵之间估计的差异(以及单侧97.5%置信区间的上限)为7.8(14.4)%,琥珀胆碱与2.5毫克/千克罗库溴铵之间为4.0(10.2)%。对于这两个比较,单侧置信区间的上限均超过了预先设定的10%差异。因此,无法证明两种剂量的罗库溴铵的插管条件不劣于1.0毫克/千克琥珀胆碱的插管条件。罗库溴铵组在前5分钟内心率增加明显更大,但仅琥珀胆碱组动脉压显著升高(P < 0.001)。给予琥珀胆碱、2.0毫克/千克和2.5毫克/千克罗库溴铵后,分别有4.0%、13.5%和18.5%的患者出现呼吸副作用(P < 0.05)。由于无法证明2.0和2.5毫克/千克罗库溴铵后插管条件具有非劣效性,琥珀胆碱应被视为能为快速顺序诱导提供更好插管条件的神经肌肉阻滞剂。