Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:11 AM
Study NCT ID:
NCT07469332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Moderate- and High-Dose Glucocorticoids on Postoperative Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Nausea and Vomiting (PONV)', 'timeFrame': '30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively'}, {'measure': 'CRP', 'timeFrame': 'preoperative and up to 18 hours postoperatively'}, {'measure': 'Quality of Recovery (QoR-15 Score)', 'timeFrame': '18 hours after surgery'}, {'measure': 'wbc', 'timeFrame': 'preoperative and up to 18 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain Intensity (VAS)', 'timeFrame': '30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively'}, {'measure': 'Intraoperative Remifentanil Consumption', 'timeFrame': 'Intraoperative period'}, {'measure': 'Postoperative Opioid Consumption', 'timeFrame': 'Up to 18 hours postoperatively'}, {'measure': 'Rescue Analgesic Requirement', 'timeFrame': 'Up to 18 hours postoperatively'}, {'measure': 'Shoulder Pain', 'timeFrame': 'Up to 18 hours postoperatively', 'description': 'Postoperative Shoulder Pain assessed by Visual Analog Scale (VAS)'}, {'measure': 'Adverse Events', 'timeFrame': 'Intraoperative and up to 10 days postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative Recovery', 'Postoperative Pain', 'dexamethasone', 'Postoperative Nausea and Vomiting', 'high dose', 'moderate dose'], 'conditions': ['Postoperative Recovery', 'PONV']}, 'descriptionModule': {'briefSummary': 'Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure; however, postoperative pain, nausea, and delayed recovery remain clinically relevant problems. Glucocorticoids such as dexamethasone are widely used in perioperative care for the prevention of postoperative nausea and vomiting and as part of multimodal analgesia strategies.\n\nThis prospective randomized controlled trial aims to compare the effects of moderate- and high-dose intravenous dexamethasone administered intraoperatively on postoperative recovery in patients undergoing elective laparoscopic cholecystectomy. The primary outcomes include postoperative nausea and vomiting, inflammatory markers (CRP and WBC), and Quality of Recovery-15 (QoR-15) scores. Secondary outcomes include postoperative pain scores, intraoperative remifentanil consumption, postoperative opioid consumption, and adverse events.', 'detailedDescription': 'Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive surgical procedures worldwide. Although it is associated with shorter hospital stay and faster recovery compared with open surgery, patients frequently experience postoperative pain, nausea, and delayed functional recovery. Effective perioperative strategies aimed at improving recovery and reducing postoperative complications remain an important component of enhanced recovery protocols.\n\nGlucocorticoids, particularly dexamethasone, are widely used in perioperative care due to their anti-inflammatory, antiemetic, and analgesia-sparing properties. Perioperative dexamethasone administration has been shown to reduce postoperative nausea and vomiting (PONV) and may contribute to improved pain control and overall recovery. However, the optimal dose of dexamethasone for maximizing recovery outcomes while maintaining safety remains unclear.\n\nThis prospective randomized controlled study is designed to evaluate whether higher doses of intraoperative dexamethasone provide additional benefits in postoperative recovery compared with moderate doses or placebo in patients undergoing elective laparoscopic cholecystectomy. Patients undergoing elective surgery will be randomly assigned to receive either moderate-dose dexamethasone, high-dose dexamethasone, or placebo as part of perioperative management.\n\nAll patients will receive standardized anesthesia management and multimodal analgesia according to institutional practice. Postoperative recovery will be evaluated using patient-reported recovery quality scores, inflammatory markers, and commonly assessed clinical outcomes including postoperative nausea and vomiting, pain intensity, and analgesic requirements.\n\nThe findings of this study may help clarify the dose-response relationship of perioperative dexamethasone and provide evidence to guide optimal dosing strategies aimed at improving postoperative recovery after laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 65 years\n* ASA physical status I-II\n* Scheduled for elective laparoscopic cholecystectomy\n* Undergoing general anesthesia\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Patients younger than 18 years or older than 65 years\n* Known allergy to dexamethasone\n* ASA physical status III or higher\n* Surgical procedures lasting longer than 120 minutes\n* Emergency surgeries\n* Pregnant or breastfeeding patients\n* Patients with coagulopathy or receiving anticoagulant therapy\n* Known allergy to local anesthetics\n* Localized infection at the injection site\n* Inflammatory bowel disease\n* Autoimmune diseses\n* Chronic pain conditions\n* Ocular herpes simplex infection\n* Cushing's disease\n* Myasthenia gravis\n* Anticipated poor compliance with the study protocol\n* Vaccination within the last 14 days\n* Use of systemic glucocorticoids or immunosuppressive drugs\n* İmpaired renal function (GFR \\< 30 mL/min)\n* Liver cirrhosis\n* Congestive heart failure\n* Peripheral nerve disorders\n* Elective laparoscopic cholecystectomy due to malignancy\n* Conversion to open surgery during the operation\n* Epilepsy\n* Body mass index (BMI) \\> 30 kg/m²"}, 'identificationModule': {'nctId': 'NCT07469332', 'briefTitle': 'Comparison of the Effects of Moderate- and High-Dose Glucocorticoids on Postoperative Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of the Effects of Moderate- and High-Dose Glucocorticoid Administration on Postoperative Recovery: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'E2-25-10587'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D1: Moderate-dose dexamethasone', 'interventionNames': ['Procedure: TAP Block', 'Drug: moderate dose Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'D2: High-dose dexamethasone', 'interventionNames': ['Procedure: TAP Block', 'Drug: High dose dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'S: Control (normal saline)', 'interventionNames': ['Other: Saline (0.9% NaCl)', 'Procedure: TAP Block']}], 'interventions': [{'name': 'Saline (0.9% NaCl)', 'type': 'OTHER', 'description': 'Intravenous normal saline 4 mL administered intraoperatively to S group', 'armGroupLabels': ['S: Control (normal saline)']}, {'name': 'TAP Block', 'type': 'PROCEDURE', 'description': 'Oblique subcostal TAP block is administered to all groups', 'armGroupLabels': ['D1: Moderate-dose dexamethasone', 'D2: High-dose dexamethasone', 'S: Control (normal saline)']}, {'name': 'moderate dose Dexamethasone', 'type': 'DRUG', 'description': 'Intravenous dexamethasone administered intraoperatively at 0.1 mg/kg (D1)', 'armGroupLabels': ['D1: Moderate-dose dexamethasone']}, {'name': 'High dose dexamethasone', 'type': 'DRUG', 'description': 'Intravenous dexamethasone administered intraoperatively at 0.2 mg/kg (D2; maximum 20 mg).', 'armGroupLabels': ['D2: High-dose dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Şemsi Mustafa AKSOY, Study Director', 'role': 'CONTACT', 'email': 'drsmaksoy@gmail.com', 'phone': '00905056212081'}], 'facility': 'Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'GÜL ŞİRİN KOÇ, MD', 'role': 'CONTACT', 'email': 'glcintosun@gmail.com', 'phone': '00905057779798'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}