Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:35 PM
Study NCT ID:
NCT01394406
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2011-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-04', 'studyFirstSubmitDate': '2011-07-13', 'studyFirstSubmitQcDate': '2011-07-13', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': 'within 48 hrs after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'Ketamine added to intravenous patient-controlled analgesia may be effective on prevention of postoperative nausea and vomiting by reducing opioid requirement after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smoking female patients undergoing elective lumbar spinal surgery\n* Age 20-65\n* American Society of Anesthesiologists physical status classification I or II\n\nExclusion Criteria:\n\n* Antiemetic within 24 hrs, Taking Steroids, Opioids within 1 week\n* Psychiatric disease, Active drug or alcohol abuse\n* GI motility disorder, severe renal/ hepatic disease\n* insulin-dependent DM\n* admission to ICU after surgery'}, 'identificationModule': {'nctId': 'NCT01394406', 'briefTitle': 'Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery', 'orgStudyIdInfo': {'id': '4-2009-0670'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine group', 'interventionNames': ['Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline group', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'ketamine 3 mg/kg mixed to intravenous patient controlled analgesia device (fentanyl 20 mcg/kg. total volume 180 ml, basal infusion 2 ml, bolus 2ml, lock-out 15 min)', 'armGroupLabels': ['Ketamine group']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'equal volume of normal saline mixed to intravenous patient controlled analgesia device', 'armGroupLabels': ['Saline group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}