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

ConditionsGIT FunctionCholecystectomy, LaparoscopicDexamethasoneDexmedetomidineI-FEED Score
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBenha University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

. 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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Group D (Dexamethasone)Active comparator 1 intervention
Group B: Group X (Dexmedetomidine)Active comparator 1 intervention
Group C: Group DX (Combination)Active comparator 1 intervention
Group D: Group P (Placebo)Placebo comparator 1 intervention

Trial outcomes

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

Time frame
24 -48 hours post operative

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov
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