Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-03-01 @ 3:40 AM
Study NCT ID:
NCT05414006
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2022-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of S-ketamine in Cesarean Section Combined Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D006930', 'term': 'Hyperalgesia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}, {'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum pain score (NRS socre) at 0-24 hours postoperatively', 'timeFrame': 'From ending of the surgery to 24 hours postoperatively', 'description': 'NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful'}, {'measure': 'Pain score (NRS socre) at 0-6 hours postoperatively', 'timeFrame': 'From ending of the surgery to 6 hours postoperatively', 'description': 'NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful'}, {'measure': 'Pain score (NRS socre) at 6-12 hours postoperatively', 'timeFrame': 'From 6 hours postoperatively to 12 hours postoperatively', 'description': 'NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful'}, {'measure': 'Pain score (NRS socre) at 12-24 hours postoperatively', 'timeFrame': 'From 12 hours postoperatively to 24 hours postoperatively', 'description': 'NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful'}], 'secondaryOutcomes': [{'measure': 'The number of patient controlled analgesia pump pressed', 'timeFrame': '0-48 hours postoperatively', 'description': 'When the patients felt pain, the patient controlled analgesia pump can be pressed once'}, {'measure': 'Patient controlled analgesia pump analgesic consumption', 'timeFrame': '0-48 hours postoperatively', 'description': 'The amount of the analgesic consumption'}, {'measure': 'Pressure pain threshold at 30min after surgery', 'timeFrame': 'Change from baseline to 30 minutes postoperatively', 'description': 'Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2'}, {'measure': 'Pressure pain threshold at 24 hours after surgery', 'timeFrame': 'Change from baseline to 30 min postoperatively', 'description': 'Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2'}, {'measure': 'Pressure pain tolerance at 30min hours after surgery', 'timeFrame': 'Change from baseline to 24 hours postoperatively', 'description': 'Pressure pain tolerance was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['S-ketamine', 'Cesarean Section', 'hyperalgesia'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '39170110', 'type': 'DERIVED', 'citation': 'Zhang J, Sun D, Wang J, Chen J, Chen Y, Shu B, Huang H, Duan G. Exploring the Analgesic Efficacy and mechanisms of low-dose esketamine in pregnant women undergoing cesarean section: A randomized controlled trial. Heliyon. 2024 Jul 30;10(15):e35434. doi: 10.1016/j.heliyon.2024.e35434. eCollection 2024 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'To compare the anti-hyperalgesia effect between S-ketamine with placebo for Maternal receiving elective Cesarean Section under Combined spinal and epidural analgesia.\n\nBased on this study the investigators intend to verify the role and potential mechanism of S-ketamine combined anesthesia in alleviating hyperalgesia after cesarean section, prove that it can reduce hyperalgesia and postoperative pain. explore the role of S-ketamine in alleviating postoperative hyperalgesia in different PCA ways and explore the safety of S-ketamine in the perilactation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA status I-III\n* Age 20 to 45\n* 37-42 weeks gestation\n* undergo elective cesarean section with subarachnoid anesthesia\n* participate in this study and sign informed consent\n\nExclusion Criteria:\n\n* Patients with contraindications for cesarean section\n* Patients with contraindications of combined spinal and epidural anesthesia\n* Patients with severe systemic disease\n* Alcoholism and long-term use of anti-inflammatory and analgesic drugs\n* Patients who were unable to cooperate or refused to participate in the trial\n* Patients with contraindications to esketamine and hydromorphone'}, 'identificationModule': {'nctId': 'NCT05414006', 'briefTitle': 'Effect of S-ketamine in Cesarean Section Combined Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Effect of S-ketamine in Cesarean Section Combined Anesthesia', 'orgStudyIdInfo': {'id': 'S-ketamine and CS hyperalgesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group E1', 'description': 'S-ketamine was administered intravenously after delivery，patient controlled epidural analgesia（PCEA）was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml', 'interventionNames': ['Drug: S-ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Group E2', 'description': 'S-ketamine was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA) was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml', 'interventionNames': ['Drug: S-ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C1', 'description': 'placebo was administered intravenously after delivery，patient controlled epidural analgesia（PCEA) was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml', 'interventionNames': ['Drug: S-ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C2', 'description': 'placebo was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA） was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml', 'interventionNames': ['Drug: S-ketamine']}], 'interventions': [{'name': 'S-ketamine', 'type': 'DRUG', 'otherNames': ['Patient controlled analgesia'], 'description': 'S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively', 'armGroupLabels': ['Group C1', 'Group C2', 'Group E1', 'Group E2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'HUANG HE, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Within five years', 'ipdSharing': 'YES', 'description': 'The individual participant data for this study is available from the sponsor on reasonable request through email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}