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

Benha University

Status: Not yet enrolling

Conditions: GIT Function; I-FEED Score; Dexmedetomidine; Cholecystectomy, Laparoscopic; Dexamethasone

Treatments: Drug: Placebo; Drug: Dexmedetomidine; Drug: Dexamethasone and dexmedetomidine; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07329933

RC.3.11.2025

Details and patient eligibility

About

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

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- . Age 18-65 years. 2. American Society of Anesthesiologists (ASA) physical status I or II. 3. Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia.

4. Ability to provide written informed consent

Exclusion criteria

• Known allergy or contraindication to any study drug (dexamethasone, dexmedetomidine, or placebo).

  2. Pre-existing gastrointestinal motility disorders (e.g., gastroparesis, inflammatory bowel disease).

  3. Chronic use of opioids, steroids, or antiemetics. 4. History of severe cardiac disease (e.g., high-grade AV block, severe bradycardia).

  5. Uncontrolled diabetes mellitus (HbA1c > 8.0%). 6. Emergency surgery or conversion to open surgery. 7. Pregnancy or breastfeeding. 8. Morbid obesity (BMI >40). 9. Severe hepatic or renal dysfunction.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

Group D (Dexamethasone)

Active Comparator group

Treatment:

Drug: Dexamethasone

Group X (Dexmedetomidine)

Active Comparator group

Treatment:

Drug: Dexmedetomidine

Group DX (Combination)

Active Comparator group

Treatment:

Drug: Dexamethasone and dexmedetomidine

Group P (Placebo)

Placebo Comparator group

Treatment:

Drug: Placebo