Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05892705
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2023-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-28', 'studyFirstSubmitDate': '2023-05-14', 'studyFirstSubmitQcDate': '2023-05-28', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of subarachnoid dexmedetomidine on hemodynamic parameters.', 'timeFrame': 'Two hours', 'description': 'Measure heart rate, blood pressure, temperature, oxygen saturation'}], 'secondaryOutcomes': [{'measure': 'Effect of subarachnoid dexmedetomidine on incidence of postoperative nausea and vomiting (PONV) and shivering.', 'timeFrame': 'Six hours', 'description': 'Note occurrence of postoperative nausea or vomiting and note occurrence of shivering and measure the degree.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrathecal Dexmedetomidine']}, 'descriptionModule': {'briefSummary': 'Background: Highly selective α-2 agonist dexmedetomidine in increasingly used as an intrathecal adjuvant for caesarean section performed under subarachnoid block.\n\nAim of the Study: The aim of the study is to determine whether low dose dexmedetomidine added to local anesthetic for spinal anesthesia will attenuate perioperative nausea and vomiting and shivering in lower segment caesarean section (LSCS) with minimal hemodynamic instability or not.\n\nPatients and Methods: Sixty parturients planned for elective CSs under spinal anesthesia were enrolled in this prospective controlled study and randomly divided into two equal groups. Spinal block was achieved with 10mg hyperbaric bupivacaine 0.5% plus 5µg dexmedetomidine (group D) (dexmedetomidine group) or 0.2 ml normal saline (group C) (control group). Hemodynamic parameters, incidence of nausea and vomiting and shivering were recorded.\n\nKeywords: Dexmedetomidine, Cesarean Section, Bupivacaine, Spinal Anesthesia, Shivering, PONV'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically free pregnant Female from 18 to 30 yrs old.\n* Undergoing elective LSCS.\n* Body mass index less than 40.\n* Consenting for sub arachnoid anesthesia.\n* Coagulation profile is within normal ranges.\n\nExclusion Criteria:\n\n* Emergency LSCS.\n* Patient refusal enrollment in the study.\n* Allergy to the medications.\n* Coagulopathy or anticoagulation drugs.\n* Fetal or Maternal comorbidities.'}, 'identificationModule': {'nctId': 'NCT05892705', 'briefTitle': 'Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Can Subarachnoid Dexmedetomidine Decrease the Incidence of Postoperative Nausea and Vomiting and Shivering With Minimal Hemodynamic Instability in CS?', 'orgStudyIdInfo': {'id': 'FAMSU R 120 / 2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study drug (dexmedetomidine intrathecal)', 'description': '5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.', 'interventionNames': ['Drug: Dexmedetomidine Injection [Precedex]']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control (saline)', 'description': '0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.', 'interventionNames': ['Drug: Dexmedetomidine Injection [Precedex]']}], 'interventions': [{'name': 'Dexmedetomidine Injection [Precedex]', 'type': 'DRUG', 'description': 'intrathecal injection of 5 mcg dexmedetomidine', 'armGroupLabels': ['Control (saline)', 'Study drug (dexmedetomidine intrathecal)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Abbasia', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Shaimaa Mohamed Samir Ezzat Rakhia', 'investigatorAffiliation': 'Ain Shams University'}}}}