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Recruiting NCT07329933

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

No phase Interventional GIT Function Cholecystectomy, Laparoscopic Dexamethasone Dexmedetomidine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexamethasone, Dexmedetomidine, Dexamethasone and dexmedetomidine, Placebo.
Who it may be relevant to
Registry conditions: GIT Function, Cholecystectomy, Laparoscopic, Dexamethasone, Dexmedetomidine. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

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

Primary outcome measures

  • The highest I-FEED score [Time frame: 24 -48 hours post operative]
Secondary outcome measures (7)
  • Time (hours) to first flatus and first defecation [Time frame: 24-48 hours post operative]
  • Time to tolerate oral intake. [Time frame: 24-48 hours postoperative]
  • incidence of POGD (defined as I-FEED score > 2) [Time frame: 24-48 hours postoperative]
  • postoperative nausea and vomiting (PONV), Incidence and severity [Time frame: 24-48 hours]
  • • Length of hospital stay (days) from surgery to discharge [Time frame: 1 week post operative]
  • • Any adverse events related to study drugs [Time frame: 24-48 hours postoperative]
  • Total rescue opioid consumption [Time frame: 24-48 hours postoperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

Egypt · 1 center
  • Benha University Hospital — Banhā

Identifiers

NCT: NCT07329933 · RC.3.11.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗