Comparative evaluation of Fentanyl versus Butorphanol during induction with Propofol on LMA insertion conditions
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Jaw relaxation according to Young’s criteria
研究概览
简要总结
This study is a randomized, double blind, parallel group, single-centre trail comparing the efficacy of intravenous Fentanyl 1 microgram/kilogram versus intravenous Butorphanol 20 microgram/kilogram as adjunct drugs during Propofol induction on LMA insertion conditions in 60 patients over a time period of 6 months which will be conducted in Department of Anaesthesiology, Government Medical College, Thiruvananthapuram, India. The primary outcome measure will be jaw relaxation according to Young’s criteria at 60 seconds after the adjunct drug and Propofol is administered. The secondary outcomes will be overall LMA insertion conditions according to modified Scheme of Lund and Stovener at 60 seconds after the adjunct drug and Propofol is administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males or females of age group 18 to 55 years who comes under the American Society of Anaesthesiologists (ASA) Physical Status I and II for short surgical procedures who need LMA for maintaining general anaesthesia.
排除标准
- •Patients of the American Society of Anaesthesiologists (ASA) Physical Status III and IV, those who suffer from pharyngeal pathology, low pulmonary compliance or history of allergy to Propofol, Butorphanol and Fentanyl.
结局指标
主要结局
Jaw relaxation according to Young’s criteria
时间窗: 60 seconds following the studied drug and Propofol is administered
次要结局
- Overall LMA insertion condition according to modified Scheme of Lund and Stovener(60 seconds following the studied drug and Propofol is administered)