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

NCT ID: NCT07329933

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-06-01

Brief Summary

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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

Detailed Description

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Conditions

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GIT Function Cholecystectomy, Laparoscopic Dexamethasone Dexmedetomidine I-FEED Score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group D (Dexamethasone)

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Group X (Dexmedetomidine)

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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 DX (Combination)

Group Type ACTIVE_COMPARATOR

Dexamethasone and dexmedetomidine

Intervention Type 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 P (Placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Dexamethasone 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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Taghreed Elshahat Sakr

lecturer of anesthesia and icu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Benha University Hospital

Banhā, , Egypt

Site Status

Countries

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Egypt

Facility Contacts

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Taghreed Sakr, MD degree of anesthesia

Role: primary

00201112723187

Other Identifiers

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RC.3.11.2025

Identifier Type: -

Identifier Source: org_study_id

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