Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-06-21 @ 5:47 PM
Study NCT ID:
NCT03613961
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2018-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Propofol Induction Anaesthesia on the Heart Rate Variability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000777', 'term': 'Anesthetics'}], 'ancestors': [{'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2018-07-29', 'studyFirstSubmitQcDate': '2018-07-29', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HRV dynamics', 'timeFrame': '2 minutes', 'description': 'Evaluate the changes in heart rate variability at different propofol concentration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Autonomic Nervous System Imbalance']}, 'referencesModule': {'references': [{'pmid': '34588990', 'type': 'DERIVED', 'citation': 'Wang HY, Lo MT, Chen KH, Mandell S, Chang WK, Lin C, Ting CK. Strong Early Phase Parasympathetic Inhibition Followed by Sympathetic Withdrawal During Propofol Induction: Temporal Response Assessed by Wavelet-Based Spectral Analysis and Photoplethysmography. Front Physiol. 2021 Sep 13;12:705153. doi: 10.3389/fphys.2021.705153. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration.', 'detailedDescription': 'Because the ANS, especially the sympathetic nervous system, plays a major role in regulating cardiovascular homeostasis, knowledge of how anesthetic agents modify sympathetic activity is important for understanding subsequent cardiovascular responses.\n\nSpectral analysis of heart rate variability (HRV) is a promising new approach, widely used, noninvasive technique to assess the autonomic indexes of neural cardiac control and has been correlated to the integrity and balance of the sympathetic and parasympathetic activation status. The presence of low-frequency (LF) and high-frequency (HF) oscillatory rhythms in the variability of the R-R interval (RRI) is well established. To date, it is believed that LF is mediated by the parasympathetic and sympathetic systems, whereas HF is mediated primarily by the parasympathetic system. There has been a lot of methodological analysis developed to evaluate the ANS function during anesthesia. In this study, Continuous Wavelet Transform (CWT), believed as a reliable and robust method to access cardiorespiratory dynamics of the ANS due to its adaptability and adjustability between spectral and temporal scale using a window of variable width, was used as a method for analyzing dynamic cardiovascular signals during anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients scheduled for surgery under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subjects were selected from patients scheduled for surgery under general anesthesia.\n\nExclusion Criteria:\n\n* recent administration of sedative or opioid drugs, emergency surgery and impairment of renal, hepatic, cardiac or respiratory function.'}, 'identificationModule': {'nctId': 'NCT03613961', 'briefTitle': 'Effects of Propofol Induction Anaesthesia on the Heart Rate Variability', 'organization': {'class': 'OTHER', 'fullName': 'National Central University'}, 'officialTitle': 'Differential Effects of Propofol Induction Anaesthesia on the Heart Rate Variability Dynamics', 'orgStudyIdInfo': {'id': 'VGHTPE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anesthetics', 'type': 'DRUG', 'description': 'The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration. We will observe the relationship of anesthetics and HRV dynamics.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11217', 'city': 'Taipei', 'state': 'R.o.c', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'all collected IPD, that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Central University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Taipei Veterans General hospital, attending doctor of anesthesiology', 'investigatorFullName': 'Hsin-Yi Wang', 'investigatorAffiliation': 'National Central University'}}}}