跳至主要内容
临床试验/CTRI/2014/08/004905
CTRI/2014/08/004905已完成不适用

Comparative Evaluation Of Propofol-Ketamine And Propofol-Fentanyl For Laryngeal Mask Airway Insertion

Institute1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Differences in insertion conditions for LMA insertion as assessed by a 6 variable, 3 point LMA insertion score

研究概览

简要总结

This was a double-blinded,randomized, controlled study, conducted in adult, ASA 1 and 2 patients,undergoing elective surgical procedures. 120 patients, satisfying the inclusionand exclusion criteria, were randomly allocated into two groups,propofol-ketamine (PK) and propofol-fentanyl (PF), each group consisting of 60patients, by sealed envelope technique. The study was designed to compare thehemodynamic responses to induction & insertion of LMA and the insertionconditions between propofol- ketamine and propofol- fentanyl combinations.

All patients received 0.3mg Glycopyrrolate, intramuscular,half an hour before the procedure.  Inthe operating room, after recording the baseline parameters- oxygen saturation(SpO2), Mean Blood Pressure (BP), Pulse Rate (PR) and End Tidalcarbon dioxide (EtCO2), 1µg/ kg Fentanyl to the PF group & 0.5mg/kg Ketamine to the PK group was given intravenously. Induction of anesthesiawas initiated with 1% Propofol @ 1mg/ kg/ min with a syringe pump, till thepatient tolerated a full jaw thrust, which was considered as the end point forLMA insertion. On reaching the end point, LMA insertion was attempted throughthe classical approach, as described by Brain. Proper position of LMA wasascertained by the ability to easily ventilate the lungs (assessed by chestmovement), without any significant resistance or leak and no significantresistance to expiration with rapid refilling of the reservoir bag. Acapnograph was also used to assess adequacy of ventilation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 and 2 adults scheduled for elective surgical procedures under general anesthesia.

排除标准

  • Contraindication for LMA usage
  • History of allergic reactions to any of the study drugs.

结局指标

主要结局

Differences in insertion conditions for LMA insertion as assessed by a 6 variable, 3 point LMA insertion score

时间窗: Induction of general anesthesia and LMA insertion

次要结局

  • Hemodynamic responses (blood pressure and heart rate) to LMA insertion(Upto 10 minutes following insertion of LMA)

研究者

发起方
Institute
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验