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Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07329933

Study of Dexamethasone, Dexmedetomidine, and Their Combination on Postoperative Gastrointestinal Function After Elective Laparoscopic Gallbladder Surgery

Led by Benha University · Updated on 2026-07-20

160

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Dexamethasone, Dexmedetomidine, and their combination on postoperative gastrointestinal GIT function in adults aged 18 to 65 undergoing elective laparoscopic cholecystectomy surgery. The study aims to compare these drugs with a placebo to understand their impact on GIT function measured by the I-FEED score after surgery. This trial is a randomized controlled study sponsored by Benha University. Participants will be randomly assigned to one of four groups Dexamethasone 8 mg IV with saline, Dexmedetomidine 0.5 mcgkg IV with saline, a combination of Dexamethasone 8 mg IV and Dexmedetomidine 0.5 mcgkg IV with saline, or placebo saline IV. Each infusion is administered over 10 minutes after anesthesia induction. The study uses a parallel design with quadruple masking to ensure unbiased results. During the study, participants will be monitored for gastrointestinal function using the highest I-FEED score measured 24 to 48 hours after surgery. Additional assessments include time to first flatus and defecation, time to tolerate oral intake, incidence of postoperative gastrointestinal dysfunction, nausea and vomiting severity, length of hospital stay, adverse events related to study drugs, and opioid consumption. The study completion is expected by August 2026, with participant involvement including treatment administration and postoperative evaluations within the first 48 hours and follow-up for up to one week after surgery.

CONDITIONS

Brief Title

Dexamethasone, Dexmedetomidine and Their Combination on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I or II
  • Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Known allergy or contraindication to dexamethasone, dexmedetomidine, or placebo
  • Pre-existing gastrointestinal motility disorders such as gastroparesis or inflammatory bowel disease
  • Chronic use of opioids, steroids, or antiemetics
  • History of severe cardiac disease including high-grade AV block or severe bradycardia
  • Uncontrolled diabetes mellitus with HbA1c greater than 8.0%
  • Emergency surgery or conversion to open surgery
  • Pregnancy or breastfeeding
  • Morbid obesity with BMI over 40
  • Severe liver or kidney dysfunction

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