Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT06288035
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessors will be blinded to the group allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone at night before surgery. The primary outcome will be the incidence of postoperative nausea and vomiting. 814 patients are intended to be recruited for this non-inferiority trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 814}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-08', 'studyFirstSubmitDate': '2024-02-24', 'studyFirstSubmitQcDate': '2024-02-24', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Surgical Site Infection (at follow-up)', 'timeFrame': 'within 2 weeks - on the follow-up', 'description': 'as evaluated by the surgeon'}, {'measure': 'Itching or burning sensation on dexamethasone injections', 'timeFrame': 'during injection of the dexamethoasone', 'description': 'Dichotomous yes/no outcome'}], 'primaryOutcomes': [{'measure': 'Postoperative nausea or vomiting (PONV)', 'timeFrame': '24 hours after surgery', 'description': 'incidecne of PONV'}], 'secondaryOutcomes': [{'measure': 'Rescue antiemetic', 'timeFrame': '24 hours after surgery', 'description': 'need for rescue antiemetic for 24 hours after surgery (Dichotomous yes/no outcome)'}, {'measure': 'Early PONV', 'timeFrame': 'within 6 hours after surgery', 'description': '(Dichotomous yes/no outcome)'}, {'measure': 'Late PONV', 'timeFrame': '6 - 24 hours after surgery', 'description': '(Dichotomous yes/no outcome)'}, {'measure': 'Visual Analogue Scale (VAS) at the time of discharge from PACU', 'timeFrame': 'within 2 hours at the time of discharge from PACU', 'description': 'On VAS scale as numerical outcome'}, {'measure': 'VAS at the time of discharge from hospital', 'timeFrame': 'after 24 hours at the time of discharge from the hospital', 'description': 'On VAS scale as numerical outcome'}, {'measure': 'Postoperative fatigue', 'timeFrame': 'after 24 hours at the time of discharge from the hospital', 'description': 'on a 10-point scale'}, {'measure': 'Postoperative quality of recovery', 'timeFrame': 'after 24 hours at the time of discharge from the hospital', 'description': 'using the QoR-15 questionnaire'}, {'measure': 'Post-Discharge Nausea and Vomiting (PDNV)', 'timeFrame': '72 hours after surgery.', 'description': 'evaluated by telephone as a binary outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy.', 'detailedDescription': 'Background:\n\nPostoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after oral administration.\n\nMethods:\n\nThis is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone 12 hours before induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 814 patients are intended to be recruited for this non-inferiority trial.\n\nDiscussion:\n\nThe current randomized trial is exploring the non-inferiority and feasibility of oral dexamethasone at night to reduce the PONV after laparoscopic cholecystectomy when compared to the standard of care - intravenous dexamethasone at the time of induction. Additionally, the investigators suppose oral dexamethasone at night is easier to administer, avoids polypharmacy at the time of induction of anesthesia, avoids the unpleasant sensation of intravenous injection, and is at a lower cost for a one-day surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery.\n\nExclusion Criteria:\n\n* steroids or antiemetics within 1 week of surgery\n* chronic opioid therapy\n* history of allergy to any of the study drug\n* serum creatinine \\> 1.4 mg/dl\n* liver enzymes \\> triple the normal limits\n* pregnancy\n* patient refusal\n* and psychiatric or neurologic diseases or socioeconomic status that would hinder the postoperative quality of recovery questionnaire\n* laparoscopic surgery is converted to open surgery after enrollment'}, 'identificationModule': {'nctId': 'NCT06288035', 'briefTitle': 'Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Oral Dexamethasone at Night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'R.21.02.1191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'At-night oral dexamethasone', 'description': 'Patients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded.', 'interventionNames': ['Drug: Dexamethasone Oral']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'At-induction dexamethasone', 'description': 'Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensations in injection.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone Oral', 'type': 'DRUG', 'description': 'Patients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded.', 'armGroupLabels': ['At-night oral dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensations in injection.', 'armGroupLabels': ['At-induction dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Moataz M Emara, MD, EDAIC', 'role': 'CONTACT', 'email': 'mm.emara@mans.edu.eg', 'phone': '01064048848'}], 'facility': 'Mansoura University Faculty of Medicine', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Moataz M Emara, MD, EDAIC', 'role': 'CONTACT', 'email': 'mm.emara@mans.edu.eg', 'phone': '+201064048848'}], 'overallOfficials': [{'name': 'Moataz M Emara, MD, EDAIC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Within one year after the completion of the study', 'ipdSharing': 'YES', 'description': 'Data will be available with the principal investigator on a reasonable request after approval of the local IRB.', 'accessCriteria': 'Will be reported after completion of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}