Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-31 @ 9:21 PM
Study NCT ID:
NCT05840328
Status:
UNKNOWN
Last Update Posted:
2023-05-03
First Post:
2023-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-07-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain relief', 'timeFrame': 'at 30 min after induction of block', 'description': 'VAS score from 0 to 10 will be assesed'}, {'measure': 'pain relief', 'timeFrame': 'on delivery', 'description': 'VAS score from 0 to 10'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Painless Vainal Labour']}, 'descriptionModule': {'briefSummary': 'compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '19 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full term (≥ 37 weeks) healthy primigravida parturients ASA2\n* with single fetus scheduled for vaginal delivery\n* with cephalic presentation\n* requesting labor analgesia.\n\nExclusion Criteria:\n\n* Allergy to dexmetomidine.(based on previous history)\n* Cardiac conduction abnormalities.(all degrees of heart block , tachyarrythmias)\n* Twins.\n* Malpresentation.\n* Preeclampsia or gestational hypertension\n* Uncontrolled diabetes HBA1c ≥ 6.5%\n* Uncontrolled renal failure\n* Uncontrolled liver disease\n* Bleeding tendency or coagulopathy.\n* Contraindication or patient refusal to epidural block.\n* Body mass index ≥ 35.'}, 'identificationModule': {'nctId': 'NCT05840328', 'briefTitle': 'DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'INTRAVENOUS Versus EPIDURAL DEXMEDETOMIDINE for ANALGESIA in NORMAL VAGINAL DELIVERY: A RANDOMIZED CONTROLED STUDY', 'orgStudyIdInfo': {'id': '11/2022ANET49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'plan group', 'description': 'bupivacaine will be administered epidurally as a loading dose then epidural continuous infusion with 0.125 % bupivacaine at rate 10 ml will be a maintainance for analgesia .IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml \\\\hr.', 'interventionNames': ['Drug: Bupivacaine Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'epidural group', 'description': '10 ml of 0.125 % buoivacaine with 0.5 µg\\\\ml dexmetomidine as a loading dose then continuous epidural infusion of 0.125% bupivacaine with 0.5µ/ml dexmetomidine at a rate of 10 ml\\\\hr will be used as maintainance . IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml\\\\hr', 'interventionNames': ['Drug: Dexmedetomidine Injection [Precedex]', 'Drug: Bupivacaine Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intravenous group', 'description': 'continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine', 'interventionNames': ['Drug: Dexmedetomidine Injection [Precedex]', 'Drug: Bupivacaine Injection']}], 'interventions': [{'name': 'Dexmedetomidine Injection [Precedex]', 'type': 'DRUG', 'description': 'interventional drug will be administred either intravenously or epidurally', 'armGroupLabels': ['epidural group', 'intravenous group']}, {'name': 'Bupivacaine Injection', 'type': 'DRUG', 'description': 'intervention drug will be administred epidurally', 'armGroupLabels': ['epidural group', 'intravenous group', 'plan group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32513', 'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ghada Ali', 'role': 'CONTACT', 'email': 'ghadaali132@yahoo.com', 'phone': '01001775783'}, {'name': 'ashraf m eskandr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'ghada ali', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'nehal elsafty', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Menoufia University Hospitals', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'centralContacts': [{'name': 'mostafa S mansour, MD', 'role': 'CONTACT', 'email': 'mostafa.said@med.menofia.edu.eg', 'phone': '01225484055'}], 'overallOfficials': [{'name': 'mostafa M mansour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Menoufia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'mostafa saieed fahim mansour', 'investigatorAffiliation': 'Menoufia University'}}}}