Actively Recruiting
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
Eligibility Criteria
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
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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