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NCT Number: NCT07329933

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

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

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Key information

Conditions

GIT Function Cholecystectomy, Laparoscopic Dexamethasone Dexmedetomidine I-FEED Score

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Egypt

Location status: Recruiting

Location contact

Taghreed Sakr, MD degree of anesthesia

CONTACT

[email protected]

00201112723187

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • . 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 criteria

  • 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.

Treatment and study plan

Dexamethasone

Drug

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

Dexmedetomidine

Drug

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

Dexamethasone and dexmedetomidine

Drug

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

Placebo

Drug

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

Primary outcomes

  1. The highest I-FEED score

    Time frame: 24 -48 hours post operative

    recorded daily from Postoperative Day (POD) 1 to POD 2. The I FEED score is calculated based on five components: Intake, Feeling nauseated, Emesis, Examination, and Duration of symptoms

Secondary outcomes

  1. Time (hours) to first flatus and first defecation

    Time frame: 24-48 hours post operative

  2. Time to tolerate oral intake.

    Time frame: 24-48 hours postoperative

  3. incidence of POGD (defined as I-FEED score > 2)

    Time frame: 24-48 hours postoperative

  4. postoperative nausea and vomiting (PONV), Incidence and severity

    Time frame: 24-48 hours

  5. • Length of hospital stay (days) from surgery to discharge

    Time frame: 1 week post operative

  6. • Any adverse events related to study drugs

    Time frame: 24-48 hours postoperative

  7. Total rescue opioid consumption

    Time frame: 24-48 hours postoperative

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: vomiting

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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