跳至主要内容
临床试验/CTRI/2023/01/049073
CTRI/2023/01/049073已完成不适用

A comparative study of melatonin and gabapentin in reducing preoperative anxiety

AIIMS New delhi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Difference in the change in VAS anxiety score

研究概览

简要总结

Reductionin preoperative anxiety reduces postoperative pain, improves post surgeryrecovery and even leads to early discharge. In addition providing analgesiabefore the start of surgery(Preemptive analgesia) has been also been associatedwith reduced postoperative pain. Patients suffering from trauma have highstress levels making them it even more pertinent to tackle preoperative anxietyand pain. Through this project we intend to find the appropriate premedicationwhich reduces preoperative anxiety and thereby reduces postoperative pain andthus improves patient outcome.

ExpectedOutcome**:** It isexpected that melatonin will be superior to alprazolam and gabapentin inreducing preoperative anxiety as well as postoperative analgesic requirements.

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 65.00 Year(s)(—)
性别
All

入选标准

  • •PAtients undergoing routine surgery after trauma ASA I and asa II patients.

排除标准

  • •a)Patients for emergency surgeries b)Surgeries taking place after 1pm (to account for diurnal variation in cortisol levels) c)Patients having altered mental state, history of psychiatric disorder, history of drug abuse or those on chronic pain medication.

结局指标

主要结局

Difference in the change in VAS anxiety score

时间窗: Difference in the change in VAS anxiety score at 90 minutes after drug administration

次要结局

  • Change in IL6 and serum cortisol levels(90 minutes post drug administration)

研究者

发起方
AIIMS New delhi
申办方类型
Research institution

研究点 (1)

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