The Effect of Dexmedetomidine and Remifentanil Infusion on Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- incidence of postoperative sore throat at rest
研究概览
简要总结
This study was performed to compare the effect of dexmedetomidine and remifentanil on the incidence and severity of postoperative sore throat in patients undergoing spinal surgery in the prone position who are at risk of developing postoperative sore throat.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status classification I and II
- •Undergoing lumbar spine surgery in prone position
排除标准
- •Pre-existing sore throat, hoarseness, or upper respiratory tract infection
- •Allergy to the study drugs
- •Anticipated difficult airways
- •More than two attempts at intubation
研究组 & 干预措施
dexmedetomidine infusion group
dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery
干预措施: dexmedetomidine infusion (Drug)
remifentanil infusion group
remifentanil of 0.05 ㎍/kg/h during induction, followed by remifentanil infusion (0.05-0.3 ㎍/kg/h) during the surgery
干预措施: remifentanil infusion (Drug)
结局指标
主要结局
incidence of postoperative sore throat at rest
时间窗: 1 hour after surgery
0=none; 1=occur
incidence of postoperative sore throat at swallowing
时间窗: 1 hour after surgery
0=none; 1=occur
severity of postoperative sore throat at rest
时间窗: 1 hour after surgery
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
severity of postoperative sore throat at swallowing
时间窗: 1 hour after surgery
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
次要结局
未报告次要终点
研究者
Eun Kyung Choi
Professor
Yeungnam University College of Medicine