A Randomised Double-Blind Controlled Study to Evaluate the Efficacy of Low-Dose Intravenous Ketamine Versus Intravenous Lignocaine for Prevention of Pain Associated With Intravenous Injection of Propofol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Difference in number of cases who experience pain on injection in both groups.
研究概览
简要总结
Propofol (2,6-diisopropylphenol) is currently the most widely used intravenous anesthetic agent due to its favorable pharmacological profile, including smooth induction, effective sedation, rapid recovery, and anti-emetic properties compared to agents such as thiopental
However, its use is frequently accompanied by a significant drawback: pain on injection, which is a common and distressing issue for patients.
The pain associated with propofol injection is believed to be primarily due to the concentration of free propofol in the aqueous phase of the emulsion .As a phenol derivative, propofol can irritate the skin, mucous membranes, and venous intima. Injection pain may be immediate, due to direct irritation of afferent nerve endings, or delayed.
Various strategies have been proposed to mitigate this pain, including altering the temperature or concentration of propofol, using larger veins for injection, and pre-treatment with intravenous agents such as lidocaine, ondansetron, metoclopramide, opioids, magnesium, or thiopental, with or without a tourniquet.
Among these, lidocaine pre-treatment remains the most commonly used method to reduce propofol injection pain.However, lidocaine does not entirely eliminate the discomfort.
Ketamine, known for its potent analgesic and local anesthetic effects, has also been explored as a potential alternative.As an NMDA receptor antagonist, ketamine may reduce pain through peripheral mechanisms and central modulation of pain pathways
Furthermore, ketamine’s sympathetic stimulatory effects can help stabilize hemodynamics following propofol administration, a potential added benefit over lidocaine
Variability in pain perception.
This study compares lignocaine and ketamine in prevention of pain associated with iv injection of propofol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 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
- •ASA grade I, II
- •Elective surgical procedure under general anesthesia
- •Patients willing to give written informed consent.
排除标准
- •Patients having known allergy to propofol and anesthetic agents will be used in study.
- •Hemodynamically unstable patient, Pregnant women, morbidly obese, history of neurological & psychological disorders, with acute or chronic pain syndromes, patients with difficulty in communication and patients who had received any sedatives and analgesic medications before surgery 3.Patients who are unwilling to participate in the study.
结局指标
主要结局
1. Difference in number of cases who experience pain on injection in both groups.
时间窗: To assess and compare prevention of pain associated with iv injection of propofol in both groups at different time intervals.
次要结局
- 1. Difference in hemodynamic variations from base line at different time interval in(both groups.)