Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 7:15 PM
Study NCT ID:
NCT01634594
Status:
COMPLETED
Last Update Posted:
2019-03-19
First Post:
2012-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008313', 'term': 'Malocclusion, Angle Class III'}], 'ancestors': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-15', 'studyFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in QTc, Tp-e interval during deliberate hypotension', 'timeFrame': 'Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery'}], 'secondaryOutcomes': [{'measure': 'Changes in Tp-e interval during deliberate hypotension', 'timeFrame': 'Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Deliberate hypotension, QTc, Tp-e, heart rate variability'], 'conditions': ['Mandibular Prognathism', 'Mandibular Retrognathism']}, 'descriptionModule': {'briefSummary': "Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Several different regimens are used to lower the patient's blood pressure, such as vasodilators, autonomic nervous system inhibitors, opioids and inhalation anesthetics. However, the effects that these agents have on the QTc and Tp-e intervals during deliberate hypotension is not known. Virtually every kind of anesthetic is reported to have some effect on the QTc and Tp-e intervals. Because orthognathic surgery usually takes 3-4 hours to complete, the amount of anesthetics and drugs used to maintain low blood pressure is not small. Therefore, the effect that these agents may have on the QTc and Tp-e intervals may not be negligible. The investigators of the present study found that the high dose of commonly used hypotensive agents tend to prolong these variabilities to some extent. This study will be able to provide insight as to which hypotensive anesthesia regimen has the least effect on the QTc and Tp-e intervals, and therefore will be helpful in minimizing cardiovascular risks of deliberate hypotensive anesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA class 1\n2. Adults over the age of 20\n3. Patients requiring deliberate hypotensive anesthesia for orthognathic surgery\n\nExclusion Criteria:\n\n1. Patient refusal\n2. Patients with arrhythmia\n3. Patients with cardiac anomalies or past history of cardiac surgery\n4. Patients with abnormal electrolyte levels\n5. Patients taking medications that are known to prolong QT intervals\n6. Patients with QTc intervals greater than 440ms\n7. Illiterate patients'}, 'identificationModule': {'nctId': 'NCT01634594', 'briefTitle': 'The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2012-0242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sevoflurane-remifentanil (group R)', 'description': 'Continuous infusion of remifentanil at 0.05 \\~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC', 'interventionNames': ['Drug: Group R']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sevoflurane-nicardipine (group N)', 'description': 'Continuous infusion of nicardipine at 1 \\~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC', 'interventionNames': ['Drug: Group N']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sevoflurane-dexmedetomidine (group D)', 'description': 'Continuous infusion of dexmedetomidine at 0.2 \\~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC', 'interventionNames': ['Drug: Group D']}], 'interventions': [{'name': 'Group R', 'type': 'DRUG', 'otherNames': ['Continuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC'], 'armGroupLabels': ['sevoflurane-remifentanil (group R)']}, {'name': 'Group N', 'type': 'DRUG', 'otherNames': ['Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC'], 'armGroupLabels': ['sevoflurane-nicardipine (group N)']}, {'name': 'Group D', 'type': 'DRUG', 'otherNames': ['Continuous infustion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC'], 'armGroupLabels': ['sevoflurane-dexmedetomidine (group D)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Young Jun Oh', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}