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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group D (Dexamethasone) | Active Comparator |
| |
| Group X (Dexmedetomidine) | Active Comparator |
| |
| Group DX (Combination) | Active Comparator |
| |
| Group P (Placebo) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Participants will receive Dexamethasone 8 mg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University Hospital | Banhā | Egypt |
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| 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 |
|
| 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 |
| • Any adverse events related to study drugs | 24-48 hours postoperative |
| Total rescue opioid consumption | 24-48 hours postoperative |
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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