跳至主要内容
临床试验/CTRI/2024/09/074438
CTRI/2024/09/074438尚未招募不适用

Comparative Evaluation of oral Melatonin and Pregabalin as premedicants for perioperative anxiety and post operative pain in daycare surgeries-A Randomized control trial

Reeya Mathew1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年10月1日

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To check for effective analgesia between study groups using Visual Analogue Score(VAS)

研究概览

简要总结

After getting approval from ethical committee, Patients posted for daycare surgeries will be taken up for study after obtaining written and informed consent. Pre-anaesthetic checkup will be done and those patients who fit into the inclusion criteria will be analyzed thoroughly and taken up for the study. Patients will be randomized into two groups, the Melatonin group and the Pregabalin group. Melatonin group patients will receive 3mg of Tab. Melatonin 6 hours before surgery. The other group will be given Tab. Pregabalin 75mg 6 hours before surgery. Patient will be kept NPO 8 hours before surgery. VAS, Anxiety Score and Sedation score will be noted at the time intervals from the beginning of premedication 4th hourly.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age: 18 years to 60 years
  • Patients undergoing daycare surgeries
  • Both Sex 4.

排除标准

  • Not willing
  • Patient on long term analgesics and opioid containing drugs
  • Allergy to those medications
  • Pregnant and lactating women.

结局指标

主要结局

To check for effective analgesia between study groups using Visual Analogue Score(VAS)

时间窗: baseline, 4th hour, 8th hour

次要结局

  • To evaluate anxiety relieving effect and sedation between two groups using Beck Anxiety Inventory Scale and Observer Assessment Alertness Scale(baseline, 4th hour, 8th hour)

研究者

发起方
Reeya Mathew
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Reeya Mathew

Shri Sathya Sai Medical College and Research Institute

研究点 (1)

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