Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-01 @ 4:56 PM
Study NCT ID:
NCT06985992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine-Dexamethasone Combination in Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Spinal anesthesia will be administered to 120 pregnant patients scheduled for elective cesarean section, using either a combination of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL saline, or a combination of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL (2 mg) dexamethasone, depending on the group to which they are randomized.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative nausea-vomiting', 'timeFrame': 'For 24 hours after surgery', 'description': 'The incidence of postoperative nausea and vomiting will be scored from 0 to 3. No nausea or vomiting attacks will be graded as 0, a nausea attack that resolves without treatment will be graded as 1, recurrent nausea attacks that resolve with treatment will be graded as 2, and persistent nausea or vomiting attacks will be graded as 3.'}, {'measure': 'Postoperative itching', 'timeFrame': 'For 24 hours after surgery', 'description': 'The degree of pruritus will be assessed on a scale of 0 to 3, with 0 being categorized as no pruritus; 1 as mild pruritus; 2 as moderate pruritus; and 3 as severe pruritus.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative Mean Blood Pressure', 'timeFrame': 'Intraoperatively every 5 minutes', 'description': 'Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.'}, {'measure': 'Intraoperative Heart Rate', 'timeFrame': 'Intraoperatively every 5 minutes', 'description': 'Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caesarean section', 'morphine', 'dexamethasone', 'nausea-vomiting', 'postoperative complications'], 'conditions': ['Caesarean Section']}, 'referencesModule': {'references': [{'pmid': '33650930', 'type': 'BACKGROUND', 'citation': 'Ankouni T, Kanawati S, El Khatib R, El Hassan J, Itani SE, Rajab O, Naja Z. Ondansetron versus ondansetron with dexamethasone to prevent intrathecal-morphine pruritus for caesarean patients: randomised double-blind trial. J Obstet Gynaecol. 2021 Oct;41(7):1080-1086. doi: 10.1080/01443615.2020.1852538. Epub 2021 Mar 2.'}, {'pmid': '39011433', 'type': 'BACKGROUND', 'citation': 'Nasiri A, Abutorabi SM, Sane S. Intrathecal dexamethasone-bupivacaine combination with bupivacaine alone in spinal anesthesia for cesarean delivery. Caspian J Intern Med. 2024 Summer;15(3):414-420. doi: 10.22088/cjim.15.3.414.'}, {'pmid': '38666154', 'type': 'BACKGROUND', 'citation': 'Ahmed SA, Lotfy HA, Mostafa TAH. The effect of adding dexmedetomidine or dexamethasone to bupivacaine-fentanyl mixture in spinal anesthesia for cesarean section. J Anaesthesiol Clin Pharmacol. 2024 Jan-Mar;40(1):82-89. doi: 10.4103/joacp.joacp_396_22. Epub 2024 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine+Dexamethasone Combination added to bupivacaine in elective cesarean section under spinal anesthesia', 'detailedDescription': 'The study will be designed as a double-blind, randomized clinical trial and will be conducted following approval by the local ethics committee. A total of 120 patients, aged 18-40 years, with an ASA physical status of II and scheduled for elective cesarean section, will be included. All patients will undergo standard preparation for spinal anesthesia. Two large-bore intravenous lines will be inserted in each patient upon arrival in the operating room. Participants will be randomly assigned to one of two groups (n = 60 per group) using sealed opaque envelopes.\n\nGroup I (morphine group) will receive spinal anesthesia consisting of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL saline.\n\nGroup II (morphine+dexamethasone group) will receive a mixture of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL (2 mg) dexamethasone.\n\nIntraoperative hemodynamic parameters (including age, height, and weight), ASA scores, postoperative complications (such as nausea, vomiting, and pruritus), and postoperative pain levels will be recorded and analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for caesarean sections\n* Between 18-40 years\n* ASA II group\n* Those who will undergo spinal anesthesia\n* Those between 35-40 weeks of pregnancy\n* 1st and 2nd caesarean sections\n\nExclusion Criteria:\n\n* Those who prefer general anesthesia\n* Those who are outside the age range of 18-40\n* Those who are ASA III and above\n* Those with HT, DM, cardiac and respiratory diseases\n* Preeclampsia, eclampsia, HELLP\n* Those with a history of drug use that affects the cardiovascular system\n* Placenta Previa, Placenta Acreta, Placenta Acreta Those with a history of antiemetic or antidepressant drug use'}, 'identificationModule': {'nctId': 'NCT06985992', 'briefTitle': 'The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine-Dexamethasone Combination in Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine-Dexamethasone Combination in Cesarean Delivery: A Prospective Randomized Double-Blind Clinical Trial', 'orgStudyIdInfo': {'id': '2025/04-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group morfin', 'description': 'Group Morphine: Spinal anesthesia will be applied to patients who will undergo caesarean section using a combination of 2 ml (10 mg) bupivacaine + 0.1 ml (100 mcg) morphine + 0.5 ml saline.', 'interventionNames': ['Procedure: Group morphine']}, {'type': 'EXPERIMENTAL', 'label': 'Group morfin+dexamethasone', 'description': 'Group morfin+dexamethasone: Spinal anesthesia will be applied to patients who will undergo a caesarean section using a combination of 2 ml (10 mg) bupivacaine + 0.1 ml (100 mcg) morphine + 0.5 ml (2 mg) dexamethasone.', 'interventionNames': ['Procedure: Group morfin+dexamethasone']}], 'interventions': [{'name': 'Group morphine', 'type': 'PROCEDURE', 'otherNames': ['Group I'], 'description': 'Group Morphine: Spinal anesthesia will be applied to patients who will undergo caesarean section using a combination of 2 ml (10 mg) bupivacaine + 0.1 ml (100 mcg) morphine + 0.5 ml saline', 'armGroupLabels': ['Group morfin']}, {'name': 'Group morfin+dexamethasone', 'type': 'PROCEDURE', 'otherNames': ['Group II'], 'description': 'Group morfin+dexamethasone: Spinal anesthesia will be applied to patients who will undergo a caesarean section using a combination of 2 ml (10 mg) bupivacaine + 0.1 ml (100 mcg) morphine + 0.5 ml (2 mg) dexamethasone', 'armGroupLabels': ['Group morfin+dexamethasone']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nurettin KURT, assoc.Prof.', 'role': 'CONTACT', 'email': 'dr.nurettinkurt@gmail.com', 'phone': '+90 4322150473'}, {'name': 'Nurettin KURT, assoc.Prof.', 'role': 'CONTACT', 'email': 'dr.nurettinkurt@hotmail.com', 'phone': '+90 05445262921'}], 'overallOfficials': [{'name': 'Nurettin KURT, Assoc.Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'YüzüncüYıl'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '10 months', 'ipdSharing': 'YES', 'description': 'Study protocol anda statistical analysis plan will be share with other researchers', 'accessCriteria': 'The access can be provided via the e-mail addresses below dr.nurettinkurt@gmail.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nurettin KURT', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}