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临床试验/NCT03058263
NCT03058263已完成1 期

The Effectiveness of Neostigmine on the Recovery of Rocuronium-Induced Neuromuscular Blockade: A Comparison Between Partial Dose and TOF Ratio-Based Adjustment Dose

Indonesia University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
66
试验地点
1
主要终点
TOF ratio with partial dose of neostigmine

研究概览

简要总结

This study aimed to evaluate the effect of Neostigmine partial dose towards neuromuscular blockade of rocuronium

详细描述

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannula with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on the subjects in the operation room. After preoxygenation was given with 100% oxygen, general anesthesia induction was done with midazolam 0.01-0.02 mg/kg, fentanyl 3 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Following induction, endotracheal intubation or laryngeal mask insertion was performed. Maintenance was done by sevoflurane 1.2 vol%, and fentanyl 1.2 mcg/kg. After the surgery had finished, fentanyl drip was stopped. Subjects were then observed until spontaneous breaths occured adequately (tidal volume ≥ 5 ml/kg) before train of four (TOF) ratio was evaluated using acceleromyography (AMG). Before reversal (neostigmine) was given, anesthetic gas was stopped and duration of operation as well as post-operative TOF ratio was recorded. The time since reversal was given then recorded. Group A received neostigmine partial dose (0.02 mg) in combination with atropine 0.4 mg for every milligram of neostigmine. Group B received TOF ratio-based dose of neostigmine in combination with atropine 0.4 mg for every milligram of neostigmine. After administration of neostigmine, TOF ratio was measured every 5 minutes until TOF ratio of ≥ 90% was achieved, and finally definitive airway could be removed. For Group A, another partial dose of neostigmine was given after 10 minutes from the first reversal dose if the TOF ratio of ≥90% had not been reached. For Group B, another TOF ratio-based dose of neostigmine was given after 10 minutes from the first reversal dose if the TOF ratio of ≥90% had not been reached. Subjects were then transported to recovery room. Data was analyzed using Statistical Package for the Social Sciences (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged 18-60 years old
  • American Society of Anesthesiologists (ASA) physical status I-II who were planned to undergo any elective surgery at operating room in general anesthesia
  • subjects had been explained about the study, and agreed to enroll and have signed the informed consent form

排除标准

  • had any severe kidney or liver disease
  • had neuromuscular disease or asthma
  • Drop out Criteria:
  • Duration of operation less than one hour or more than 2 hours
  • during surgery received maintenance dose of neuromuscular block
  • intraoperative cardiac arrest was occurred

研究组 & 干预措施

partial dose of neostigmine

Experimental

Those who received partial dose of neostigmine as rocuronium reversal

干预措施: Dose of Neostigmine (Drug)

TOF ratio-based dose of neostigmine

Experimental

Those who received TOF ratio-based dose of neostigmine as rocuronium reversal

干预措施: Dose of Neostigmine (Drug)

结局指标

主要结局

TOF ratio with partial dose of neostigmine

时间窗: Day 1

Train-of-Four ratio obtained from post-operative acceleromyography after the first partial dose of neostigmine had been administrated until definitive airway device can be removed

TOF ratio with TOF ratio-based dose of neostigmine

时间窗: Day 1

TOF ratio between partial dose of neostigmine and TOF ratio-based dose of neostigmine

时间窗: Day 1

time needed to reach TOF ratio ≥ 90% in group with partial dose of neostigmine

时间窗: Day 1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arif H. M. Marsaban

Anesthesiologist Consultant

Indonesia University

研究点 (1)

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