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临床试验/NCT05699876
NCT05699876招募中不适用

A Comparative Study of Melatonin and Gabapentin as Premedication for Patients Undergoing Surgery Following Trauma

All India Institute of Medical Sciences, 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15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
preoperative anxiety

研究概览

简要总结

This project aims to compare the effect of preoperative administration of melatonin and gabapentin in reducing preoperative anxiety, stress markers and postoperative pain levels in trauma patients undergoing surgery. Gabapentin has analgesic as well as sedative properties. Melatonin, a hormone has been extensively used in intensive care units and has found to improve the sleep cycle and reduce pain. It is now being explored as a preoperative medication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Melatonin

Experimental

干预措施: Melatonin 6 MG (Drug)

Gabapentin

Active Comparator

干预措施: Gabapentin (Drug)

结局指标

主要结局

preoperative anxiety

时间窗: 30 minutes after drug administration

evaluate the difference in the preoperative anxiety score(Numerical Rating Scale ) before and after drug administration

次要结局

  • post operative analgesia(24 hours postoperative)
  • inflammatory markers(before and 30 minutes after drug administrartion)
  • Sedation score(before and 30 minutes after drug administrartion)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelika Prakash

Assistant Professor

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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