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临床试验/CTRI/2025/05/087701
CTRI/2025/05/087701尚未招募不适用

Comparison of the effects of dexmedetomidine, lignocaine and ketamine pretreatment on propofol injection pain: a randomized clinical trial.

Regional Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2025年5月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
156
试验地点
1
主要终点
Intensity of pain during propofol injection

研究概览

简要总结

This randomized, double-blind, comparative clinical study aims to evaluate the effectiveness of three pharmacological agents-dexmedetomidine, ketamine and lignocaine-reducing pain associated with intravenous propofol injection during anaesthesia induction. A total of 156 patients (ASA physical status I and II), schedule for elective surgeries under general anaesthesia, will be enrolled and randomly assigned to one of three groups. Group D will receive 0.25mcg/kg dexmedetomidine, Group K will receive 0.5mg/kg, and Group L will receive 0.5mg/kg lignocaine each diluted in 5ml of normal saline administered intravenously before propofol injection. Pain response will be evaluated using a standardized four point scale. The findings will help determine the most effective pretreatment strategy for minimizing propofol injection pain.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
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 of age group 18 to 60 years.
  • Patients of ASA-PS grade I or II.

排除标准

  • Patients with history of allergy to propofol and the study drugs.
  • Patients with anticipated difficult venous access.
  • Patients with neurological deficits or psychiatric disorders.
  • Patients with history of drug abuse (alcohol, sedative, and analgesic).
  • Patients with cardiac disease (hemodynamically unstable, ischaemic heart disease), hepatic, renal, pulmonary disease and seizures Patients with morbid obesity.
  • Patients with pregnancy and breastfeeding.
  • Patients with acute or chronic pain syndromes.
  • Patients with disorders of lipid metabolism.
  • Patients with thrombophlebitis.

结局指标

主要结局

Intensity of pain during propofol injection

时间窗: Intensity of pain during propofol injection, assessed using a verbal response scale within 30 seconds of propofol administration.

次要结局

  • Heamodynamic changes (hypotension, bradycardia, hypertension, tachycardia) after propofol administration.(Heamodynamic changes (hypotension, bradycardia, hypertension, tachycardia) baseline before, during and 1, 3 minutes after propofol administration.)

研究者

申办方类型
Government medical college

研究点 (1)

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