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临床试验/NCT03173339
NCT03173339已完成不适用

Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia

Keimyung University Dongsan Medical Center1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
Number of participants with sore throat

研究概览

简要总结

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the dose of remifentanil.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-III
  • Patients scheduled for general anesthesia with endotracheal intubation

排除标准

  • Difficult airway
  • Rapid sequence induction
  • Recent sore throat
  • Recent upper respiratory infection
  • Chronic obstructive pulmonary disease
  • Chronic cough
  • Pregnancy
  • Allergy to remifentanil
  • Friable teeth
  • History of head and neck surgery
  • Multiple intubation attempts
  • Regional anesthetic agents
  • Gastric tube
  • Dexamethasone

研究组 & 干预措施

Low remifentanil and high sevoflurane

Active Comparator

Remifentanil was administered as 0.1 mcg/kg/min. Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.

干预措施: Endotracheal intubation using laryngoscope (Procedure)

Low remifentanil and high sevoflurane

Active Comparator

Remifentanil was administered as 0.1 mcg/kg/min. Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.

干预措施: Low remifentanil (Drug)

Low remifentanil and high sevoflurane

Active Comparator

Remifentanil was administered as 0.1 mcg/kg/min. Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.

干预措施: High sevoflurane (Drug)

High remifentanil and low sevoflurane

Experimental

Sevoflurane was administered as 0.5 MAC. Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.

干预措施: Endotracheal intubation using laryngoscope (Procedure)

High remifentanil and low sevoflurane

Experimental

Sevoflurane was administered as 0.5 MAC. Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.

干预措施: High remifentanil (Drug)

High remifentanil and low sevoflurane

Experimental

Sevoflurane was administered as 0.5 MAC. Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.

干预措施: Low sevoflurane (Drug)

结局指标

主要结局

Number of participants with sore throat

时间窗: At 24 hr

次要结局

  • Number of participants with hoarseness(At 0, 2, 4 and 24 hr)
  • Number of participants with additional pain medication(At 0, 2, 4 and 24 hr)
  • Visual analogue scale of postoperative pain(At 0, 2, 4 and 24 hr)
  • Number of participants with sore throat(At 0, 2, 4 and 24 hr)
  • Number of participants with cough(At 0, 2, 4 and 24 hr)
  • Number of participants with nausea(At 0, 2, 4 and 24 hr)
  • Number of participants with vomiting(At 0, 2, 4 and 24 hr)
  • Number of participants with shivering(At 0, 2, 4 and 24 hr)
  • Requirements of analgesics(At 0, 2, 4 and 24 hr)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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