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临床试验/CTRI/2026/03/106848
CTRI/2026/03/106848尚未招募不适用

Evaluation of two different dose regimens of preoperative Duloxetine on Postoperative Pain After laparoscopic cholecystectomy: Randomized Controlled Trial

keerthan k p1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2026年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
122
试验地点
1

研究概览

简要总结

This study is a prospective randomized double blind trial involving 122 patients undergoing elective cholecystectomy under general anesthesia Patients are randomly divided into two groups of 61 each using a computer generated sequence with allocation concealed in sealed envelopes opened by a pharmacist not involved in the study

Group A receives duloxetine 30 mg the night before surgery and 30 mg two hours before surgery Group B receives 30 mg the night before and 60 mg two hours before surgery Both are given with small amounts of water

All patients receive standard premedication with ondansetron midazolam and glycopyrrolate Standard monitoring is applied and anesthesia is induced with fentanyl propofol and vecuronium followed by endotracheal intubation and mechanical ventilation using oxygen nitrous oxide and isoflurane Hemodynamic parameters are recorded at regular intervals after induction

At the end of surgery residual carbon dioxide is removed and neuromuscular blockade is reversed No additional intraoperative analgesics are given Duration of surgery is recorded

Postoperatively patients are monitored in the recovery unit Pain is assessed using the visual analogue scale at 2 4 8 12 and 24 hours and shoulder pain is assessed using a numeric rating scale Rescue analgesia with intravenous acetaminophen is given if pain score is 4 or more

All data including drug doses clinical parameters and patient responses are recorded for analysis

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Adult patients undergoing laparoscopic cholecystectomy.

排除标准

  • Liver or renal dysfunction Daily corticosteroid use History of duloxetine allergy Patients with cognitive psychological or communication disorders Patient with uncontrolled DM HTN and IHD Pregnant or nursing women.

研究者

发起方
keerthan k p
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Keerthan k p

shri B M Patil medical college, hospital and research centre, vijayapura

研究点 (1)

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