Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-01 @ 9:43 PM
Study NCT ID:
NCT05189704
Status:
UNKNOWN
Last Update Posted:
2023-04-13
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of PCA on PONV After Microvascular Decompression
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': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'D000701', 'term': 'Analgesics, Opioid'}], 'ancestors': [{'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}, {'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2021-12-30', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'postoperative 48 hours', 'description': 'Incidence'}], 'secondaryOutcomes': [{'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'Postoperative 30 minutes, 1 hours, 24 hours, 48 hours', 'description': 'Severity accessed using numeric rating scale (0=none, 10=worst PONV possible)'}, {'measure': 'Postoperative pain', 'timeFrame': 'Postoperative 30 minutes, 1 hours, 24 hours, 48 hours', 'description': 'pain intensity will be assessed using numeric rating scale (0=none, 10=worst pain possible)'}, {'measure': 'Postoperative PCA consumption', 'timeFrame': 'Postoperative 30 minutes, 1 hours, 24 hours, 48 hours'}, {'measure': 'Rescue antiemetics requirement', 'timeFrame': 'Postoperative 30 minutes, 1 hours, 24 hours, 48 hours'}, {'measure': 'Rescue analgesic requirement', 'timeFrame': 'Postoperative 30 minutes, 1 hours, 24 hours, 48 hours'}, {'measure': 'Satisfaction score for postoperative nausea and vomiting', 'timeFrame': 'postoperative 48 hours', 'description': 'using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)'}, {'measure': 'Satisfaction score for postoperative pain', 'timeFrame': 'postoperative 48 hours', 'description': 'using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, controlled, double-blinded, and parallel design study. A total 94 patients will be randomized to receive ketorolac or fentanyl based patient-controlled analgesia after microvascular decompression surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who undergo elective microvascular decompression surgery\n* American Society of Anesthesiologists grade 1 or 2\n* 19 - 65 years old\n\nExclusion Criteria:\n\n* Refuse to participate to the study\n* Refuse to use Patient-controlled analgesia\n* Body Mass Index \\< 18.5 kg/m2 or \\> 35 kg/m2\n* history of craniotomy or chemotheraphy\n* Patients who used preoperative antiemetics within 24h before surgery\n* Severe renal or hepatic dysfunction\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT05189704', 'briefTitle': 'The Effect of PCA on PONV After Microvascular Decompression', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Patient-controlled Analgesia (Ketorolac vs. Fentanyl) on the Development of Postoperative Nausea and Vomiting in Patients Undergoing Microvascular Decompression: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MVD-PCA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NSAID group', 'description': 'NSAID based patient-controlled analgesia will connected to intravenous line for pain control.', 'interventionNames': ['Drug: NSAID']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opioid group', 'description': 'Opioid based patient-controlled analgesia will connected to intravenous line for pain control.', 'interventionNames': ['Drug: Opioid']}], 'interventions': [{'name': 'NSAID', 'type': 'DRUG', 'description': 'NSAID based patient-controlled analgesia will connected to intravenous line for pain control.', 'armGroupLabels': ['NSAID group']}, {'name': 'Opioid', 'type': 'DRUG', 'description': 'Opioid based patient-controlled analgesia will connected to intravenous line for pain control.', 'armGroupLabels': ['Opioid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chang-Hoon Koo', 'role': 'CONTACT', 'email': 'vollock9@gmail.com'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Chang-Hoon Koo', 'role': 'CONTACT', 'email': 'vollock9@gmail.com', 'phone': '+821085098841'}], 'overallOfficials': [{'name': 'Chang-Hoon Koo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Chang-Hoon Koo', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}