跳至主要内容
临床试验/NCT05313100
NCT05313100已完成4 期

The Evaluation of the Effects of the Use of Rocuronium and Sugammadex on Neuromuscular Block in Smoker

Duzce University0 个研究点目标入组 40 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
主要终点
Neuromuscular block recovery time

研究概览

简要总结

We compared the durations of antagonizing and of the severity of effect of sugammadex used in antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of Four(TOF) neuromuscular monitorization.

详细描述

40 patients from American Society of Anesthesiologist (ASA) I- II class, being smokers for at least 10 years or non-smokers, who will undergo elective surgery were included in this randomized prospective study. Patients underwent routine monitoring and neuromuscular monitoring. Propofol 2 mg/kg and intravenous fentanyl 1 mcg/kg were applied at induction. After the loss of eyelash reflex, intravenous rocuronium 0,6 mg/kg was administered. The patient was intubated at a Train of Four count of 2. Anesthesia was continued with 50% O2 + 50% air and sevoflurane 2 % . Rocuronium 0,15 mg/kg was administered when TOF (Train of Four) counter reached 2 during the operation. Sugammadex 2 mg/kg was administered at the end of the operation. The time to reach Train of Four values of 0,7-0,8-0,9 were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

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

  • Elective surgery,
  • 1-2 according to the ASA ( American Society of Anesthesiologist ) physical status classification.
  • Patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking
  • Or never smoked patients

排除标准

  • neuromuscular diseases
  • radiotherapy and/or chemotherapy anamnesis,
  • liver and/or renal disease,
  • electrolyte balance,
  • history of drug use which affects neuromuscular transmission,
  • Body Mass Index (BMI) of more than 27,
  • use alcohol

研究组 & 干预措施

Smokers

Active Comparator

The patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking were included in the smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used.

干预措施: sugammadex (Drug)

Nonsmokers

Sham Comparator

The patients who never smoked were included in the non-smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used.

干预措施: sugammadex (Drug)

结局指标

主要结局

Neuromuscular block recovery time

时间窗: six months

Time to reach TOF %90 measurement after given neuromuscular blocker reverse agent

次要结局

未报告次要终点

研究者

发起方
Duzce University
申办方类型
Other
责任方
Sponsor

相似试验