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临床试验/CTRI/2016/12/007618
CTRI/2016/12/007618进行中(未招募)不适用

Evaluation of efficacy of valsalva manuever for attenuating propofol injection pain

Sanjay Gandhi Postgraduate Institute Of Medical Sciences Lucknow Uttar Pradesh India1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
80
试验地点
1
主要终点
To evaluate the analgesic efficacy of valsalva procedure in attenuating the propofol pain at induction of general anaesthesia

研究概览

简要总结

Aims and objectives: Primary objective: To evaluate the efficacy of valsalva procedure in attenuating propofol injection pain at induction of general anaesthesia. Methodology: Patients will be randomized with the help of a computer-generated table of random numbers into 2 groups of 40 each. Group I (Control): acted as control and did not perform valsalva; Group II (Valsalva): patients blowing into a rubber tubing connected to sphygmomanometer and raise the mercury column up to 30 mmHg for a period of at least 20 sec. Just after the intervention, all the patients will be receiving one-fourth of the total calculated dose of propofol over 5s and 15 s later till 1 minute and before the patients lost consciousness. One nursing staff who will be kept unaware of the study, will assess VAS and withdrawal response score. Exclusion: Patients with communication problem, cardiorespiratory disease, chronic pain disorder, on preoperative analgesic medication, history of propofol allergy, history of drug abuse and inability to perform valsalva Risks associated with the procedure are none as in ASA 1 patients; however, valsalva procedure has been reported to attenuate pain in animal studies and more so in humans for minimizing venous cannulation pain in adults and paediatric patients. We therefore wish to evaluate its efficacy in reducing the propofol injection pain.

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 70.00 Year(s)(—)
性别
All

入选标准

  • •ASA I patients scheduled for surgery under general anaesthesia with propofol as an induction agent.

排除标准

  • •Patient refusal Patients with communication problem Cardiorespiratory disease Chronic pain disorder, on preoperative analgesic medication, History of egg allergy, soyabean oil Inability to perform valsalva.

结局指标

主要结局

To evaluate the analgesic efficacy of valsalva procedure in attenuating the propofol pain at induction of general anaesthesia

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Sanjay Gandhi Postgraduate Institute Of Medical Sciences Lucknow Uttar Pradesh India
申办方类型
Research institution and hospital

研究点 (1)

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