Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT06233032
Status:
UNKNOWN
Last Update Posted:
2024-01-31
First Post:
2023-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Could Ephedrine Replace Dexmedetomidine Fordexmedetomidine Prevention of Shivering in Women Undergoing Cesarean Section Under Spinal Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004809', 'term': 'Ephedrine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'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': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2024-01-22', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of shivering during spinal anaesthesia in cesarean delivery .Intensity of shivering assessed using five point scale', 'timeFrame': '45min', 'description': 'one hundred Pts will be included in this study .\n\n1. fifty patients will receive Ephedrine 6 mg IV bolus before spinal block.\n2. fifty patients will be receive 30 microgram IV bolus before spinal block'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prevention of Shivering With Spinal Anaesthesia']}, 'descriptionModule': {'briefSummary': 'Could ephedrine replace dexamedetomidine for prevention of shivering in women undergoing Cesarean section Under spinal anaesthesia', 'detailedDescription': 'Shivering, rhythmic oscillatory movement of upper limbs, neck and jaw, is common during regional anesthesia with an incidence up to 56.7% of patients. Perioperative shivering is a commonly observed clinical problem well known to anesthesiologists caring for women undergoing a Cesarean delivery (CD). The median incidence of shivering in parturients having labour epidural analgesia or CD with epidural or spinal anesthesia has been estimated to be 52%.1 Severe shivering causes physiologic stress, interferes with patient monitors, and decreases the comfort and overall satisfaction of women during childbirth. Ephedrine well-known sympathomimetic agent, has been used to treat hypotension during regional anesthesia. It has antiemetic effect for short-term . Ephedrine maintained hemodynamics and minimized decrease of the core temperature when given by an intravenous infusion during spine surgery under general anesthesia . Dexmedetomidine, a selective a-2 agonist, was introduced in clinical practice in the United States in 1999. It is approved by Health Canada as a short-term sedative for mechanically ventilated adult patients in the intensive care unit and sedation of non-intubated patients prior to and/or during surgical procedures. It has since been approved and is widely used in pediatric populations and for procedural sedation of non-intubated patients.9 Nevertheless, the clinical use of dexmedetomidine has expanded to various off-label uses. In obstetrical anesthesia, it has been used as part of multi-modal intravenous labour and post-CD analgesia,10-13 as a neuraxial adjunct in the epidural space for labour,14 and intrathecally for shivering prevention during CD'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female from 18 to 35 yrs\n* uncomplicated pregnancy for elective cesarean delivery\n\nExclusion Criteria:\n\n* patient refusal\n* allergy to the drug\n* contraindications of spinal anaesthesia\n* patients with DM or thyroid disorders'}, 'identificationModule': {'nctId': 'NCT06233032', 'briefTitle': 'Could Ephedrine Replace Dexmedetomidine Fordexmedetomidine Prevention of Shivering in Women Undergoing Cesarean Section Under Spinal Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Could Ephedrine Replace Dexmedetomidine for Prevention of Shivering in Women Undergoing Cesarean Section Under Spinal Anaesthesia', 'orgStudyIdInfo': {'id': 'Prevention of shivering'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group E', 'interventionNames': ['Drug: Ephedrine']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Ephedrine', 'type': 'DRUG', 'description': 'Patient Will receive 6mg IV', 'armGroupLabels': ['Group E']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Patient Will receive 30mcg IV', 'armGroupLabels': ['Group D']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Assiut university', 'role': 'CONTACT', 'email': 'Vp_grad@aun.edu.eg', 'phone': '+209922080150'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Dina Salah Kamal, Master', 'role': 'CONTACT', 'email': 'dina14296@gmail.com', 'phone': '01009196736'}, {'name': 'Ola Mahmoud, Professor', 'role': 'CONTACT', 'phone': '01013046017'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dina Salah Kamal Salman', 'investigatorAffiliation': 'Assiut University'}}}}