Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-30 @ 9:46 AM
Study NCT ID:
NCT05053633
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2021-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between ANI, Anxiety, and Pain in Conscious Hernia Patients Undergoing CSEA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between ANI and pain (measured with Visual Analog Scale,VAS), ANI and anxiety (measured with Visual Analog Scale-Anxiety,VAS-A) changes in conscious patients during anesthesia procedures', 'timeFrame': 'The changes of ANI, VAS, and VAS-A, from baseline at different Time-points to 2min after anesthesia procedures, (Timepoints: T1=after lateral position, T2=local anesthesia, T3=epidural needle puncture, and T4=2 minutes after puncture)', 'description': 'ANI is derived from hear rate variability, ranging from 0-100, bigger number means better analgesic level. Patients undergoing CSEA may experience mid-level anxiety while remaining conscious. The anxiety (VAS-A), pain (VAS), and ANI assessments were conducted at four specific time points.'}], 'secondaryOutcomes': [{'measure': 'The correlation between pain (measured with Visual Analog Scale,VAS) and anxiety (measured with Visual Analog Scale-Anxiety,VAS-A) changes in conscious patients during anesthesia procedures', 'timeFrame': 'The changes of VAS, and VAS-A, from baseline at different Time-points to 2min after anesthesia procedures, (Timepoints: T2=local anesthesia, T3=epidural needle puncture, and T4=2 minutes after puncture)', 'description': 'The anxiety (VAS-A) and pain (VAS) were conducted at three specific time points, since there is no stimulus at lateral position (Timepoints: T2=local anesthesia, T3=epidural needle puncture, and T4=2 minutes after puncture).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Combined Spinal-epidural Anesthesia']}, 'descriptionModule': {'briefSummary': 'Analgesia Nociception Index can be used to detect noxious stimulation during general anesthesia.The aim of this study is to observe ANI under combined spinal epidural anesthesia procedures in conscious hernia patients.', 'detailedDescription': 'Analgesia Nociception Index which is derived by heart rate variability, can be used to detect noxious stimulation during general anesthesia. However, the impact of anxiety on ANI evaluation and the correlation between ANI, pain, and anxiety in awake patients remains unclear. This study aimed to investigate the correlation between ANI, pain, and anxiety in conscious hernia patients undergoing combined spinal epidural anesthesia procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with ASA status I or II, aged between 18 and 80 years old, scheduled for inguinal hernia, umbilical hernia or incisional repair under CSEA were included in the study. Participants with chronic pain, cardiovascular dysfunction, arrhythmia, dysautonomia, pacemaker usage, medication affecting the autonomic nervous system, contraindications to CSEA, or previous exposure to CSEA or surgery were excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18- 80 years\n* ASA physical status I or II\n* Scheduled for inguinal hernia, umbilical hernia or incisional repair under CSEA\n* Written informed consent\n\nExclusion Criteria:\n\n* Use of CNS-active medication or abuse of alcohol\n* History of cardiac arrhythmia\n* Contraindications of combined spinal epidural anesthesia\n* Previous exposure to CSEA or surgery'}, 'identificationModule': {'nctId': 'NCT05053633', 'briefTitle': 'Relationship Between ANI, Anxiety, and Pain in Conscious Hernia Patients Undergoing CSEA', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Relationship Between Analgesia Nociception Index, Anxiety, and Pain in Conscious Hernia Patients Undergoing Combined Spinal Epidural Anesthesia', 'orgStudyIdInfo': {'id': '00375931'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Combined spinal epidural anesthesia', 'description': 'The assessments are conducted in conscious patients under the procedure of Combined spinal epidural anesthesia.', 'interventionNames': ['Procedure: Combined spinal epidural anesthesia']}], 'interventions': [{'name': 'Combined spinal epidural anesthesia', 'type': 'PROCEDURE', 'description': 'The Anxiety (Visual Analogue Scale for Anxiety), pain (Visual Analogue Scale), and the Analgesia Nociception Index (ANI) assessments are conducted at four specific time points: lateral position, local anesthesia, epidural needle puncture and 2 minutes after puncture.', 'armGroupLabels': ['Combined spinal epidural anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chao Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy chief physician', 'investigatorFullName': 'Changwei Wei', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}