RecruitingNot ApplicableNCT07329933

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

Effect of Dexamethasone, Dexmedetomidine and Their Combination on Postoperative Gastrointestinal Function Measured by I-FEED Score After Elective Laparoscopic Cholecystectomy Surgery: a Randomized Controlled Trial


Sponsor

Benha University

Enrollment

160 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn the effect of Dexamethasone and Dexmedetomidine and Their Combination on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy What medical problems do participants have when taking Dexamethasone and Dexmedetomidine? Researchers will compare Dexamethasone and Dexmedetomidine and Their Combination to a placebo (a look-alike substance that contains no drug) to see the effect on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy Participants will receive Dexamethasone 8 mg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia. Participants will receive Dexmedetomidine 0.5 mcg /kg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia. Participants will receive Dexamethasone 8 mg IV + Dexmedetomidine 0.5 mcg/kg IV+ Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia. Participants will receive Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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

Exclusion Criteria9

  • Known allergy or contraindication to any study drug (dexamethasone, dexmedetomidine, or placebo).
  • Pre-existing gastrointestinal motility disorders (e.g., gastroparesis, inflammatory bowel disease).
  • Chronic use of opioids, steroids, or antiemetics.
  • History of severe cardiac disease (e.g., high-grade AV block, severe bradycardia).
  • Uncontrolled diabetes mellitus (HbA1c > 8.0%).
  • Emergency surgery or conversion to open surgery.
  • Pregnancy or breastfeeding.
  • Morbid obesity (BMI >40).
  • Severe hepatic or renal dysfunction.

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Interventions

DRUGDexamethasone

Participants will receive Dexamethasone 8 mg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.

DRUGDexmedetomidine

Participants will receive Dexmedetomidine 0.5 mcg /kg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.

DRUGDexamethasone and dexmedetomidine

Participants will receive Dexamethasone 8 mg IV + Dexmedetomidine 0.5 mcg/kg IV+ Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia

DRUGPlacebo

Participants will receive Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia


Locations(1)

Benha University Hospital

Banhā, Egypt

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NCT07329933


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