Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-26 @ 6:51 AM
Study NCT ID:
NCT01650961
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2012-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Palonosetron on the QTc Interval During Perioperative Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077924', 'term': 'Palonosetron'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2012-07-24', 'studyFirstSubmitQcDate': '2012-07-25', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'corrected QT interval (QTc interval)', 'timeFrame': 'up to 90 minutes after induction of general anesthesia', 'description': 'at 2, 10, 15, 30, 60, 90 minutes after induction of general anesthesia, up to 1 minute after tracheal intubation'}], 'secondaryOutcomes': [{'measure': 'proportion of patients whose corrected QT interval (QTc interval) is more than 450 ms for male or 470 ms for female', 'timeFrame': 'up to 2 hours after induction of general anesthesia'}, {'measure': 'corrected QT interval (QTc interval) at Postanesthetic care unit', 'timeFrame': 'up to 1 hour after arrival on postanesthetic care unit'}, {'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': 'for 24 hours after surgery'}, {'measure': 'proportion of patients who have more than 500 ms of corrected QT interval (QTc interval)', 'timeFrame': 'up to 2 hours after induction of general anesthesia'}]}, 'conditionsModule': {'conditions': ['Anesthesia, General', 'Palonosetron']}, 'referencesModule': {'references': [{'pmid': '24129597', 'type': 'DERIVED', 'citation': 'Kim HJ, Lee HC, Jung YS, Lee J, Min JJ, Hong DM, Choi EK, Oh S, Jeon Y. Effect of palonosetron on the QTc interval in patients undergoing sevoflurane anaesthesia. Br J Anaesth. 2014 Mar;112(3):460-8. doi: 10.1093/bja/aet335. Epub 2013 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective abdominal surgery under general anesthesia\n\nExclusion Criteria:\n\n* Cardiac valvular disease\n* Clinically significant arrhythmias including atrial fibrillation\n* Anti-emetics within 24 hours before surgery\n* Steroids within 1 week before surgery\n* Cancer chemotherapy or radiotherapy within 4 weeks before surgery\n* Diabetes mellitus\n* Pregnancy\n* Patients receives a QT-prolonging drug'}, 'identificationModule': {'nctId': 'NCT01650961', 'briefTitle': 'The Effect of Palonosetron on the QTc Interval During Perioperative Period', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Palonosetron on the QTc Interval During Perioperative Period', 'orgStudyIdInfo': {'id': 'YSJeon_palonosetron_QTc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palonosetron', 'description': 'Intravenous administration of palonosetron 0.075 mg before the induction of general anesthesia', 'interventionNames': ['Drug: Palonosetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Intravenous administration of normal saline before the induction of general anesthesia', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Palonosetron', 'type': 'DRUG', 'otherNames': ['Aloxi'], 'description': '0.075 mg IV as bolus before induction of general anesthesia', 'armGroupLabels': ['Palonosetron']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': '2 ml normal saline as bolus before induction of general anesthesia', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}