Optimal Dose of Combination of Rocuronium and Cisatracurium: A Randomized Double-blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- Onset of Neuromuscular Blocking Agents(NMBAs)
研究概览
简要总结
BACKGROUND: The combinations of rocuronium and cisatracurium have a synergic effect. The investigators studied whether the prediction is possible to have a sufficient effect of reducing the dose when combining the two neuromuscular blocking agents through monitoring neuromuscular relaxation during surgery.
METHODS: Each group were intubating dose group (Group I, n=27) combined Effective Dose (ED)95 rocuronium and ED95 cisatracurium, small amount reducing group (Group S, n=27) reduced 10% of each ED95 and large amount reducing group (Group L, n=27) reduced 20% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each study drug was administrated to the patient and timer was started with TOF-Watch® monitoring. Train-of-four (TOF) of the ulnar nerve was used as setting of 2 Hz per 12 sec. The investigators checked time to TOF ratio=0 (Onset), time to 1st TOF ratio>25% (Duration 25%) and TOF 25-75% (recovery index) under total i.v. anesthesia (TIVA). One way ANOVA was used for statistical analysis (α=0.05, β=0.2).
详细描述
Introduction:
Rocuronium and cisatracurium are representative neuromuscular blocking agents used widely because the former have features of fast onset of peak effect and short duration of muscle relaxation relatively while the latter have comparatively long duration relaxation time and break down by Hofmann elimination and ester hydrolysis. A combination of the two have a synergic effect may be also used with either the priming method for rapid sequence intubation. It would contribute both to determine the effective combination rate clinically and to predict the pharmacokinetic characteristics that determine how much the synergistic effect of this combination. The investigators studied whether the prediction is possible to have a sufficient effect of reducing the dose when combining the two muscle relaxants through monitoring muscle relaxation during surgery.
Materials and methods:
This study was conducted to 81 patients scheduled for elective mastoidectomy and tympanoplasty after obtaining written informed consent. All patients included the American Society of Anesthesiologists (ASA) physical status I-II, aged 20-60, BMI 20-30 kg/m2. The exclusion criteria were as follows: a history of allergy to the study drugs, neuromuscular disease, pregnancy or breast-feeding, preoperative medication of antipsychotics or neuroleptics known to interact with non-depolarizing neuromuscular blocking agents (NMBAs), serum creatinine level>1.2 mg/dL, liver transaminase>40 U/L. Anthropometric variables such as height, weight were measured in ward before surgery. BMI calculated as total body weight divided by the squared height. Ideal body weight (IBW) was calculated by the formula of Devine {50 kg + 2.3 × (height [inch]-60) for man and 45.5 kg + 2.3 × (height [inch]-60) for woman} and used to administrate NMBAs of initial dose. Lean body weight (LBW) was calculated by the formula of James {LBW (men) = (1.10 × Weight(kg)) - 128 × ( Weight2 / (100 × Height(m))2), (women) = (1.07 × Weight(kg)) - 148 × ( Weight2 / (100 × Height(m))2)}. Additive dose of NMBAs was administrated by LBW. Patients were randomly assigned to each group by opening of sealed allocation envelope. Each group were intubating dose group (Group I, n=27) combined ED95 rocuronium and ED95 cisatracurium, small amount reducing group (Group S, n=27) reduced 10% of each ED95 and large amount reducing group (Group L, n=27) reduced 20% of each ED95.
Monitoring and Medication:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the American Society of Anesthesiologists (ASA) physical status I-II
- •BMI 20-30 kg/m2
- •Patients scheduled for mastoidectomy and tympanoplasty.
排除标准
- •a history of allergy to the study drugs,
- •neuromuscular disease,
- •pregnancy
- •breast-feeding,
- •preoperative medication of antipsychotics or neuroleptics known to interact with NMBAs
- •serum creatinine level>1.2 mg/dL,
- •liver transaminase>40 U/L.
研究组 & 干预措施
10% reduction of combination of Esmeron® and Nimbex®, Group S
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
干预措施: 10% reduction of combination of Esmeron® and Nimbex® (Drug)
20% reduction of combination of Esmeron® and Nimbex®, Group L
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
干预措施: 20% reduction of combination of Esmeron® and Nimbex® (Drug)
结局指标
主要结局
Onset of Neuromuscular Blocking Agents(NMBAs)
时间窗: Intraoperative, an average of 5 minutes
Time from administration of initial NMBAs to Train-of-four (TOF) ratio=0, assessed up to 15 minutes during general anesthesia.
Duration 25% of Neuromuscular Blocking Agents(NMBAs)
时间窗: Intraoperative, an average of 1 hours
Time from administration of initial NMBAs to Train-of-four (TOF) ratio \>25%, assessed up to 2 hours during general anesthesia.
Recovery Index of Neuromuscular Blocking Agents(NMBAs)
时间窗: Intraoperative, an average of 20 minutes
Time from TOF ratio 25% to 75%, assessed up to 1 hour during general anesthesia.
次要结局
- Operation Time(Intraoperative, an average of 3 hours.)
- Anesthetic Time(Intraoperative, an average 4 hours.)
- Additional Rescue Doses Per Hour Ratio.(Intraoperative, an average of 3 hours.)
研究者
Wooyoung Park
clinical assistant professor
Yonsei University