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临床试验/CTRI/2025/03/083757
CTRI/2025/03/083757尚未招募Unknown

Comparison of effect of two different doses of intraoperative Dexmedetomidine infusion on recovery of gastrointestinal movement in adult patients undergoing emergency abdominal surgery : A randomised clinical trial

Indira Gandhi Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
120
试验地点
1
主要终点
time to first flatus in postoperative periods

研究概览

简要总结

This randomised clinical trials aims to compare the effects of two different intraoperative dexmedetomidine infusion doses on postoperative gastrointestinal recovery in adults patients undergoing emergency abdominal surgery. The study will evaluate the impact of a normal dose (loading 1 µg/kg over15 minutes followed by 0.5 µg/kg/h maintenance) versus a low dose (loading 0.5 µg/kg over 15 minutes followed by 0.2 µg/kg/h maintenance).

The primary outcome is the time ti first flatus postoperatively, serving as a key indicator for gastrointestinal recovery. Secondary outcomes include I-FEED score assesment, time to first feces, time to first oral feeding, incidence of delirium, pain scores, sleep quality, postoperative nausea and vomiting, hospital costs and length of hospital stay.

This study aims to provide evidence regarding the optimal dexmedetomidine dosing strategy to enhance gastrointestinal recovery, reduce postoperative complications and improve overall patient outcomes following emergency abdominal surgery. Findings may contribute to improved perioperative management protocols and enhanced recovery strategies in surgical patients.

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 59.00 Year(s)(—)
性别
All

入选标准

  • Body weight
  • 70 kg Patient undergoing emergency abdominal surgeries.

排除标准

  • Patient refusal Preoperative use of opioids Bradycardia Heart block greater than first degree Preoperative use of antihypertensive drugs containing clonidine or an a2-agonist Difficulty in communication Abnormal liver or renal function Bowel disease (Ulcerative Colitis, Crohns disease and IBS).

结局指标

主要结局

time to first flatus in postoperative periods

时间窗: any time during the postoperative period corrected to the nearest hour

次要结局

  • postoperative gastrointestinal function measured by I-FEED scoring system(measure over first 72 hr of postoperative period)
  • time to first feces(any time during the postoperative period corrected to nearest hour)
  • time to first oral feeding(any time during the postoperative period corrected to nearest hour)
  • incidence of delirium(measure twice daily for first 3 days during the postoperative period)
  • pain score(measure for 7 postoperative days)
  • sleep quality(measure for 7 postoperative days)
  • postoperative nausea & vomiting(measure for 7 postoperative days)
  • hospital costs(total amount of money that will spend during hospital stay)
  • hospital length of stay(total number of days patient will spend in hospital)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

NITIN KUMAR

INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

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