跳至主要内容
临床试验/NCT03391700
NCT03391700Unknown不适用

Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia

SMG-SNU Boramae Medical Center1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2017年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
206
试验地点
1
主要终点
Overall incidence of postoperative sore throat

研究概览

简要总结

Investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.

详细描述

In this sturdy, the deep block is applied when the surgeon requests for deep muscle relaxation to improve surgical field condition in the surgery such as laparotomy known that the deep block is helpful and in the other surgeries, the moderate block is maintained. The investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxation depth in the deep block group and moderate block group in terms of the incidence and severity of postoperative sore throat and hoarseness.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Requirement for mechanical ventilation under general anesthesia

排除标准

  • Hoarseness and sore throat existed before surgery
  • Upper respiratory infection
  • Known or predicted difficult airway
  • Liver, renal disease
  • Requirement of postoperative ventilator care
  • the operation within 2hrs
  • Laparoscopic surgery
  • Other positions except supine during surgery

研究组 & 干预措施

Moderate muscle relaxation

Active Comparator

Rocuronium is administered to maintain moderate relaxation during operation. This is conventional muscle relaxation level of this institute.

干预措施: Rocuronium(moderate) (Drug)

Deep muscle relaxation

Experimental

Rocuronium is administered to maintain deep relaxation during operation.

干预措施: Rocuronium(deep) (Drug)

结局指标

主要结局

Overall incidence of postoperative sore throat

时间窗: Within 24 hrs after operation

The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period

次要结局

  • The incidence of postoperative sore throat(At 1,6, and 24 hrs after operation)
  • The severity of postoperative sore throat(At 1,6, and 24 hrs after operation)
  • Incidence and severity of postoperative hoarseness(At 1,6, and 24 hrs after operation)
  • Postoperative analgesic consumption(Within 24 hrs after operation)

研究者

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

Jin-Young Hwang

associate professor

SMG-SNU Boramae Medical Center

研究点 (1)

Loading locations...

相似试验

Effect of Intraoperative Muscle Relaxation Depth on... | 临床试验