Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-07 @ 10:23 PM
Study NCT ID:
NCT06040060
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2023-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine Effects as Preemptive Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2023-09-10', 'studyFirstSubmitQcDate': '2023-09-10', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of postoperative analgesia', 'timeFrame': '24 hours post operative', 'description': 'Time interval from completion of hysterectomy until additional analgesic is needed, namely fentanyl 25 µg via PCA'}, {'measure': 'Total need for post-operative analgesic rescue', 'timeFrame': '24 hours post operative', 'description': 'The total amount of rescue analgetic required by research subjects, during the 24 hours after surgery, was given via PCA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketamine', 'Preemptive Analgesia'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to compare the effect of preemptive ketamine administration to placebo administration in patients underwent hysterectomy surgery. The main questions it aims to answer are:\n\n1. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the duration of analgesia after hysterectomy surgery\n2. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the need for fentanyl after hysterectomy surgery'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18-50 years.\n2. ASA I and II physical status (American Society of Anesthesiologists).\n\nExclusion Criteria:\n\n1. The patient is not willing to be included as a research subject\n2. The patient takes anti-pain medication before surgery\n3. History of allergies to the drugs to be used\n4. History of chronic pain'}, 'identificationModule': {'nctId': 'NCT06040060', 'briefTitle': 'Ketamine Effects as Preemptive Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Padjadjaran'}, 'officialTitle': 'Effects of Ketamine 0.5 Mg/Kgbw Administration as Preemptive Analgesia on Analgesia Duration and the Need for Fentanyl Following Hysterectomy Surgery', 'orgStudyIdInfo': {'id': 'AN-202309.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Preemptive Ketamine', 'description': 'Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision', 'interventionNames': ['Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'The intervention was prepared by the research team (anesthesia resident) in the form of ketamine which had been diluted to a dosage of 10 mg/cc, taken according to the required dose based on actual body weight then diluted with 0.9% NaCl to 10 cc. Then the two solutions were given to researchers without knowing the contents of the drugs that had been prepared by the resident who assisted in this research.', 'armGroupLabels': ['Preemptive Ketamine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'While the 0.9% NaCl solution was used as placebo was prepared in a 10 cc syringe', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40161', 'city': 'Bandung', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Universitas Padjadjaran', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}], 'overallOfficials': [{'name': 'Iwan Fuadi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine Universitas Padjadjaran Bandung'}, {'name': 'Ardi Zulfariansyah, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine Universitas Padjadjaran Bandung'}, {'name': 'Jacklin E Mokoginta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Universitas Padjadjaran Bandung'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Padjadjaran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}