跳至主要内容
临床试验/CTRI/2023/12/060528
CTRI/2023/12/060528进行中(未招募)3 期

"Comparison of intravenous pretreatment with dexmeditomedine, ketamine and preservative free lignocaine in alleviating propofol injection pain -- A prospective randomized study."

Dr Sanju Ashokkumar1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
3 期
状态
进行中(未招募)
发起方
入组人数
150
试验地点
1
主要终点
To compare the efficacy of intravenous dexmeditomedine ,ketamine and preservative free lignocaine in reducing the Intensity of pain upon injection of propofol graded on a four point scale (0-3)

研究概览

简要总结

Propofol is one of the most commonly used induction agents in anaesthesia practice.Due to its sedative and hypnotic properties, its usage in TIVA and procedural sedation has become a common practice. Continous IV infusion of propofol is also used extensively for producing IV sedation, especially in ICU setups.  Its favourable features include quick onset of action, rapidity in causing loss of consciousness, pleasant sleep and quick smooth recovery and no postoperative nausea and vomiting.

It causes pain when given intravenously, the incidence varying from 28% to 98% in adults during induction of anaesthesia. The theories for this pain include activation of plasma kallikrein-kinin system, oil emulsion preparation, osmolality of the solvent used to make the preparation and the pH of the solution. Propofol injection pain can cause sympathetic activation, may induce unwanted apprehension and anxiety, leading to an unpleasant general anaesthesia experience.

Several methods have been tried to attenuate this pain, such as increasing flow rate, injecting it into larger vein, adding various opioids, cooling/dilution of propofol and pre- treatment with other drugs like ondansetron, ephedrine, metaclopramide, nafamostate mesilate, thiopentone sodium etc. The most extensively used method is pretreatment with lignocaine. It reduces pain during propofol injection by its local anaesthetic action and also by stabilising kinin cascade. However, it has a failure rate of 13-32%.

Ketamine, a phencyclidine derivative apart from being a good general anaesthetic agent, also has analgesic and local anaesthetic effects. This can be attributed to its antagonistic action on NMDA receptors, thereby can help in reducing propofol induced pain.

Recently Alpha 2 adrenergic agonists like clonidine have also been known to alleviate propofol injection pain. A more selective alpha 2 adrenergic agonist like dexmeditomedine , which also has analgesic and sedative properties has been researched to combat this pain.

There are limited studies comparing these drugs for reduction of propofol pain. In this study, we propose to compare intravenous dexmeditomedine , intravenous ketamine and intravenous preservative free lignocaine in reducing propofol injection pain.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Patients who are willing to participate in the study
  • Patients undergoing surgeries that require general anaesthesia with propofol as induction agent
  • Age group of 18-60 of either sex
  • American society of anaesthesiologist (ASA) physical status I and II.

排除标准

  • 1.History of drug allergy 2.Patients who dont fit in the age/ ASA criteria 3.History of psychiatric disorder 4.History of seizure disorder 5.History of substance abuse.

结局指标

主要结局

To compare the efficacy of intravenous dexmeditomedine ,ketamine and preservative free lignocaine in reducing the Intensity of pain upon injection of propofol graded on a four point scale (0-3)

时间窗: 0 seconds, 30 seconds and 60 seconds

None (0) - No response to questioning

时间窗: 0 seconds, 30 seconds and 60 seconds

Mild (1) - Pain reporting in response to questioning only

时间窗: 0 seconds, 30 seconds and 60 seconds

Moderate (2) - Pain reporting in response to questioning and or pain reported spontaneously without questioning

时间窗: 0 seconds, 30 seconds and 60 seconds

Severe (3) - Strong vocal response accompanied by facial grimace, arm withdrawals or tears

时间窗: 0 seconds, 30 seconds and 60 seconds

次要结局

  • The hemodynamic variability in patients upon injecting these study agents.(0 seconds and 1 minute)

研究者

发起方
Dr Sanju Ashokkumar
申办方类型
Other [self]

研究点 (1)

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