Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:19 AM
Study NCT ID:
NCT07329933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone, Dexmedetomidine and Their Combination on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-29', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2025-12-29', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The highest I-FEED score', 'timeFrame': '24 -48 hours post operative', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Time (hours) to first flatus and first defecation', 'timeFrame': '24-48 hours post operative'}, {'measure': 'Time to tolerate oral intake.', 'timeFrame': '24-48 hours postoperative'}, {'measure': 'incidence of POGD (defined as I-FEED score > 2)', 'timeFrame': '24-48 hours postoperative'}, {'measure': 'postoperative nausea and vomiting (PONV), Incidence and severity', 'timeFrame': '24-48 hours'}, {'measure': '• Length of hospital stay (days) from surgery to discharge', 'timeFrame': '1 week post operative'}, {'measure': '• Any adverse events related to study drugs', 'timeFrame': '24-48 hours postoperative'}, {'measure': 'Total rescue opioid consumption', 'timeFrame': '24-48 hours postoperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GIT Function', 'Cholecystectomy, Laparoscopic', 'Dexamethasone', 'Dexmedetomidine', 'I-FEED Score']}, 'descriptionModule': {'briefSummary': '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\n\nWhat 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.\n\nParticipants will receive Dexmedetomidine 0.5 mcg /kg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.\n\nParticipants 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.\n\nParticipants will receive Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- . 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.\n\n4\\. Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy or contraindication to any study drug (dexamethasone, dexmedetomidine, or placebo).\n\n 2\\. Pre-existing gastrointestinal motility disorders (e.g., gastroparesis, inflammatory bowel disease).\n\n 3\\. Chronic use of opioids, steroids, or antiemetics. 4. History of severe cardiac disease (e.g., high-grade AV block, severe bradycardia).\n\n 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.'}, 'identificationModule': {'nctId': 'NCT07329933', 'acronym': 'GIT', 'briefTitle': 'Dexamethasone, Dexmedetomidine and Their Combination on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RC.3.11.2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group D (Dexamethasone)', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group X (Dexmedetomidine)', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group DX (Combination)', 'interventionNames': ['Drug: Dexamethasone and dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group P (Placebo)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Participants will receive Dexamethasone 8 mg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.', 'armGroupLabels': ['Group D (Dexamethasone)']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Participants will receive Dexmedetomidine 0.5 mcg /kg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.', 'armGroupLabels': ['Group X (Dexmedetomidine)']}, {'name': 'Dexamethasone and dexmedetomidine', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Group DX (Combination)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia', 'armGroupLabels': ['Group P (Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banhā', 'country': 'Egypt', 'contacts': [{'name': 'Taghreed Sakr, MD degree of anesthesia', 'role': 'CONTACT', 'email': 'taghreed.sakr@fmed.bu.edu.eg', 'phone': '00201112723187'}], 'facility': 'Benha University Hospital', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia and icu', 'investigatorFullName': 'Taghreed Elshahat Sakr', 'investigatorAffiliation': 'Benha University'}}}}