GIT Function, Cholecystectomy, Laparoscopic, Dexamethasone, Dexmedetomidine, I-FEED Score
Conditions
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
Interventions
DRUGDexamethasone
Participants will receive Dexamethasone 8 mg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
DRUGDexmedetomidine
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
DRUGPlacebo
Participants will receive Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The highest I-FEED score | 24 -48 hours post operative | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Time (hours) to first flatus and first defecation | 24-48 hours post operative |
| • Any adverse events related to study drugs | 24-48 hours postoperative |
| Total rescue opioid consumption | 24-48 hours postoperative |
| • Length of hospital stay (days) from surgery to discharge | 1 week post operative |
Countries
Egypt
Outcome results
None listed