Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT06213935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-19
First Post:
2024-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-30', 'releaseDate': '2025-07-12'}], 'estimatedResultsFirstSubmitDate': '2025-07-12'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D008879', 'term': 'Midodrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of post spinal anesthesia hypotension', 'timeFrame': 'within 60 minutes of induction of spinal anesthesia', 'description': 'decrease in Mean Arterial Blood Pressure more than 20% of the baseline reading'}], 'secondaryOutcomes': [{'measure': 'Intraoperative ephedrine consumption', 'timeFrame': 'within 60 minutes of induction of spinal anesthesia', 'description': 'ephedrine dose injected intravenous to control post spinal hypotension'}, {'measure': 'Incidence of post spinal anesthesia bradycardia', 'timeFrame': 'within 60 minutes of induction of spinal anesthesia', 'description': 'decrease in Heart Rate less than 50 Beats per minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Spinal Anesthesia Hypotension']}, 'referencesModule': {'references': [{'pmid': '8329261', 'type': 'BACKGROUND', 'citation': 'McCrae AF, Wildsmith JA. Prevention and treatment of hypotension during central neural block. Br J Anaesth. 1993 Jun;70(6):672-80. doi: 10.1093/bja/70.6.672.'}, {'pmid': '35950781', 'type': 'BACKGROUND', 'citation': 'Alseoudy MM, Nasr MO, Abdelsalam TA. Efficacy of Preoperative Oral Midodrine in Preventing Hypotension After Spinal Anesthesia in Young Adults: A Randomized Controlled Trial. Anesth Analg. 2022 Nov 1;135(5):1089-1096. doi: 10.1213/ANE.0000000000006173. Epub 2022 Aug 10.'}, {'pmid': '15190580', 'type': 'BACKGROUND', 'citation': 'Quaglia MG, Farina A, Palmery M, Desideri N, Donati E, Bossu E, Strano S. Chiral investigation of midodrine, a long-acting alpha-adrenergic stimulating agent. Chirality. 2004 Jul;16(6):356-62. doi: 10.1002/chir.20041.'}, {'pmid': '28873293', 'type': 'BACKGROUND', 'citation': 'Gutman LB, Wilson BJ. The Role of Midodrine for Hypotension Outside of the Intensive Care Unit. J Popul Ther Clin Pharmacol. 2017 Aug 23;24(3):e45-e50. doi: 10.22374/1710-6222.24.3.4.'}]}, 'descriptionModule': {'briefSummary': 'Neuraxial blockade such as spinal anaesthesia can cause severe hypotension due to pharmacological sympathectomy resulting in potential deleterious consequences for the patient, Prevention of this spinal anaesthesia induced hypotension is of utmost importance, Techniques currently in use for preventing hypotension include intravenous fluid prehydration, sympathomimetic drugs, and physical methods such as positioning and leg compression.\n\nMidodrine is an orally active α-adrenergic agonist ,Used in clinical management of patients with orthostatic hypotension or hypotension secondary to other clinical conditions or drug therapies. Midodrine is almost completely absorbed after oral administration and undergoes enzymatic hydrolysis to form its pharmacologically active metabolite, de-glymidodrine , causes venous and arterial vasoconstriction through stimulation of α1- receptors located in the vasculature, However ,Midodrine may cause several side effects as chills ,numbness , tingling ,paresthesia ,polyuria ,dysuria and headache.\n\nOn the other hand, Norepinephrine is a vasoconstrictor that predominantly stimulates α1 receptors to cause peripheral vasoconstriction and increase blood pressure. It also has some β1 receptor agonist activity that results in a positive inotropic effect on the heart at higher doses. Norepinephrine also may cause side effects as headache, blurred vision, chest pain ,nervousness, bradycardia or tachycardia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The study will include 90 adult female patients, 45 in each group (between 18-35 years old).\n2. patients of ASA physical status class I and class II.\n3. patients scheduled for elective cesarean section under spinal anesthesia.\n\nExclusion Criteria:\n\n1. Patient refusal.\n2. Contraindication to spinal anesthesia .\n3. Patients known allergic to Midodrine or Norepinephrine.\n4. Patients with preexisting cardiovascular or cerebrovascular disease.\n5. Patients with diabetes mellitus.\n6. Patients with psychiatric disease or on psychiatric treatment.'}, 'identificationModule': {'nctId': 'NCT06213935', 'briefTitle': 'Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Soh-Med-23-12-01MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'will receive a norepinephrine bolus at 0.05 μg/kg, followed by norepinephrine infusion at a rate of 0.05 μg/kg.min', 'interventionNames': ['Drug: Norepinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'will receive 10 mg tablets of midodrine 1 hour before spinal anesthesia.', 'interventionNames': ['Drug: Midodrine']}], 'interventions': [{'name': 'Norepinephrine', 'type': 'DRUG', 'description': 'after spinal anesthesia, norepinephrine will be injected intravenous as bolus at 0.05 μg/kg, followed by norepinephrine infusion at a rate of 0.05 μg/kg.min to prevent post spinal hypotension', 'armGroupLabels': ['group A']}, {'name': 'Midodrine', 'type': 'DRUG', 'description': '10 mg tablets of midodrine 1 hour before spinal anesthesia to prevent post spinal anesthesia hypotension', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrew R Khalafallah, Resident', 'role': 'CONTACT', 'email': 'andrewramsis@med.sohag.edu.eg', 'phone': '01284160711'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Anesthesia,Intensive Care and Pain control department, Sohag university hospital', 'investigatorFullName': 'Andrew Ramsis Khalafallah', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-12', 'type': 'RELEASE'}, {'date': '2025-07-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Andrew Ramsis Khalafallah, Resident of Anesthesia,Intensive Care and Pain control department, Sohag university hospital, Sohag University'}}}}