跳至主要内容
临床试验/CTRI/2018/05/013827
CTRI/2018/05/013827招募中Unknown

Comparison of ondansetron or lignocaine pretreatment for reduction in pain due to propofol intravenous injection: Single blind randomized study

Sri Devaraj Urs Academy of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 546 人开始时间: 2016年12月15日最近更新:

试验速览

阶段
Unknown
状态
招募中
入组人数
546
试验地点
1
主要终点
To compare the effect of ondansetron and lignocaine in reducing pain following propofol injection using Verbal Rating Scale (VRS)

研究概览

简要总结

To reduce pain due to propofol injection, various drugs have been triedsuch as lignocaine, ketorolac, paracetamol, ketamine, magnesium sulfate ortopical nitroglycerine application but complete attenuation of pain due topropofol injection was not observed. Mixing lignocaine withpropofol is most commonly used method for prevention of propofol injection pain. Ondansetron is a selective serotonin receptor antagonist (5-HT3),currently used for the prophylaxis and treatment of postoperative nausea andvomiting. Some studies have demonstrated that ondansetron can produce localanesthetic effect, probably by blocking sodium channels. It blocks theperipheral nociceptive effect of serotonin thus having antinociceptive effect. Ondansetronbinds to the opioid μ receptors and acts as an agonist.Twocomparative studies between lignocaine and ondansetron have been carried out inIndia with variable results and they had recruited 40-50 patients.7,8 Routinely ondansetron is administeredpreoperatively to prevent post-operative nausea and vomiting. Therefore,instead of another drug, ondansetron will be compared with lignocaine to assessthe analgesic effect in larger number of individuals.

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
21.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of either gender aged between 21- 50 years 2.Patients with body weight of 50-80 Kg 3.Patients undergoing elective surgeryunder general anesthesia 4.Patients belonging to American Society of Anesthesiology (ASA) physical status I and II.

排除标准

  • 1.History of allergy to study drugs 2.Pregnant and lactating women 3.Patients receiving analgesics 48 hours before surgery 4.Patients with pain posted for elective surgery.

结局指标

主要结局

To compare the effect of ondansetron and lignocaine in reducing pain following propofol injection using Verbal Rating Scale (VRS)

时间窗: Baseline and 15 seconds after propofol injection intravenoulsy

次要结局

  • To assess the adverse effect in both groups using WHO causality assessment and Naranjo probability scales(Study drugs administration to 6 hrs postoperatively)

研究者

申办方类型
Private medical college

研究点 (1)

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