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

NCT07329933 | Not Yet Recruiting

• 1 other identifier: RC.3.11.2025
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The highest I-FEED score

  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

  24 -48 hours post operative

Secondary Outcomes (7)

• Time (hours) to first flatus and first defecation

  24-48 hours post operative

• Time to tolerate oral intake.

  24-48 hours postoperative

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

  24-48 hours postoperative

• postoperative nausea and vomiting (PONV), Incidence and severity

  24-48 hours

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

  1 week post operative

Study Arms (4)

Group D (Dexamethasone)

ACTIVE COMPARATOR

Drug: Dexamethasone

Group X (Dexmedetomidine)

ACTIVE COMPARATOR

Drug: Dexmedetomidine

Group DX (Combination)

ACTIVE COMPARATOR

Drug: Dexamethasone and dexmedetomidine

Group P (Placebo)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dexamethasone DRUG

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

Group D (Dexamethasone)

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.

Group X (Dexmedetomidine)

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

Group DX (Combination)

Placebo DRUG

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

Group P (Placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- . 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.
• \. Ability to provide written informed consent

You may not qualify if:

• 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. 4. History of severe cardiac disease (e.g., high-grade AV block, severe bradycardia).
• \. 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Egypt

Location

MeSH Terms

Interventions

Dexamethasone; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and icu

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: December 15, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)