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临床试验/CTRI/2025/09/094589
CTRI/2025/09/094589尚未招募不适用

Comparative study between effect of Intravenous low dose Ketamine and Lignocaine pretreatment for prevention of pain on Propofol injection during General Anaesthesia for elective surgery in Tertiary care centre

Sapthagiri Institute of Medical Sciences and Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the analgesic effects of intraveonus low dose Ketamine v/s Lignocaine in alleviating pain following Propofol injection

研究概览

简要总结

  Brief resume of the intended work:

•Propofol is the most commonly used intravenous inducing agent internationally because of its rapid onset of action, smooth induction short duration of action, fewer side effects, and rapid recovery properties. It is also used for maintenance and sedation in the intensive care unit. The side effects of propofol include hypotension, apnea, pain on injection, and myoclonus. Pain on injection is a major problem as it causes discomfort to the patient and compromises the analgesia which is an important component of anaesthesia . Pain on injection of propofol incidence in adults ranges from 28% to 90%. Pain on propofol injection can be immediate or delayed after 10 second to 20 seconds. The pain is described as sharp, burning, or aching. Even though the pain mechanism remains unsure, several techniques have been tried to alleviate propofol pain. Altering the formulation of the drug, osmolality, pH of the drug, injection volume, temperature, speed of injection, choice of a vein and intravenous cannula size, speed of carrier intravenous fluid, buffering action of blood, and use of preemptive drugs to decrease pain.

 •Ketamine which is N-methyl-D-aspartate (NMDA) receptor antagonist has also been recognized to reduce pain induced by propofol. Also, it acts peripherally to reduce pain.

 •Lignocaine pretreatment is most commonly used to decrease propofol injection pain.Local  anaesthetic like intravenous lignocaine hydrochloride is a cation solution. When it gets exposed to lipids in propofol, it liberates protons and decreases the pH of the solution; the lower pH decreases the anions in propofol. Hence more amount of propofol enters into the lipid phase and will cause reduced pain on injection. Other drugs like Nafamostat, Ketorolac, Ephedrine, Metoclopramide, Thiopentone, and Opioids have been tried.

 •The present study is aimed at comparing the analgesic effect between intravenous ketamine and lignocaine in alleviating propofol injection pain

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA grade 1 and 2 2)Informed consent 3)Patients posted for elective surgery under general anaesthesia.

排除标准

  • Patients with known allergy to study drug 2)Pregnancy with lactating women 3)Uncontrolled Diabetes ,Hypertension,Cardiovascular or Respiratory Disorders.

结局指标

主要结局

To compare the analgesic effects of intraveonus low dose Ketamine v/s Lignocaine in alleviating pain following Propofol injection

时间窗: Pain score will be assessed every 5 seconds till 15 seconds .

次要结局

未报告次要终点

研究者

发起方
Sapthagiri Institute of Medical Sciences and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DrSeema Dharmatti

Sapthagiri Institute of Medical Sciences and Research Centre

研究点 (1)

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