Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-05 @ 5:10 PM
Study NCT ID:
NCT03387956
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-04', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2017-12-24', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative nausea', 'timeFrame': '24 hours', 'description': 'Monitoring scale of nausea and vomiting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative Nuasea'], 'conditions': ['Postoperative Nausea']}, 'descriptionModule': {'briefSummary': 'optimal postoperative pain control with intrathecal morphine, with proper prevention of postoperative nausea and vomiting. Dexamethasone, and or atropine could offer some protection against nausea and vomiting.', 'detailedDescription': 'One of the gold standards for analgesia following cesarean delivery is intrathecal morphine, which is not devoid of complications namely postoperative nausea and vomiting. We evaluated the antiemetic effect of intravenous dexamethasone combined with intrathecal atropine after cesarean delivery under spinal bupivacaine plus morphine anesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* females\n* 18-40 years of age\n* elective cesarean delivery under bupivacaine spinal anesthesia\n\nExclusion Criteria:\n\n* renal disease\n* preeclampsia\n* liver disease\n* cardiac disease\n* Coagulopathy\n* chronic cough\n* nausea\n* vomiting\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT03387956', 'briefTitle': 'Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Intravenous Dexamethasone Combined With Intrathecal Atropine to Prevent Morphine-related Nausea and Vomiting After Cesarean Delivery: A Randomized Double-blinded Study', 'orgStudyIdInfo': {'id': 'IRB00009916'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Atropine group', 'description': 'Atropine group (A): Patients received intrathecal heavy Marcaine, 2 ml, 0.5% plus 300 µg morphine and 100 µg atropine (0.5ml), and intravenous injection of 2ml normal saline.', 'interventionNames': ['Drug: Intrathecal atropine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone group', 'description': 'Dexamethasone group (D): Patients received intrathecal heavy Marcaine 2 ml, 0.5% plus 300 µg morphine (0.5ml), and intravenous 8 mg dexamethasone (2ml).', 'interventionNames': ['Drug: dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone and Atropine group', 'description': 'Dexamethasone and Atropine group (DA): Patients received intrathecally as group A, plus intravenous injection of 2 ml, dexamethasone 8 mg. Postoperative follow-up of both nausea and vomiting was done over 24 hours postoperative.', 'interventionNames': ['Drug: Intrathecal atropine', 'Drug: dexamethasone']}], 'interventions': [{'name': 'Intrathecal atropine', 'type': 'DRUG', 'description': '100ug intrathecal atropine will be injected with spinal anesthesia', 'armGroupLabels': ['Atropine group', 'Dexamethasone and Atropine group']}, {'name': 'dexamethasone', 'type': 'DRUG', 'description': 'intravenous 8 mg dexamethasone (2ml).', 'armGroupLabels': ['Dexamethasone and Atropine group', 'Dexamethasone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Emad Zarief Kamel Said', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Emad Zarief , MD', 'investigatorAffiliation': 'Assiut University'}}}}