Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT05063461
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2021-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-19', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.', 'timeFrame': 'Change from Baseline ANI that 2 minutes after applied tetanic stilumation', 'description': 'Tetanic stimulations are applied at different effect site concentrations of remifentanil under sevoflurane anesthesia. ANI is range from 0-100. Bigger number means better analgesic level. ANI≥50 is considered to be under adequate analgesia. Tetanic stimulation is a standard tester of nociceptive stimulus. The number of ANI will fall down if the patient is feeling pain.'}], 'secondaryOutcomes': [{'measure': 'The ANI predictability for tetanic noxious stimuli', 'timeFrame': 'Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation', 'description': 'ANI is range from 0-100. Bigger number means better analgesic level. ANI≥50 is considered to be under adequate analgesia. The number of ANI will fall down if the patient is feeling pain.'}, {'measure': 'The heart rate predictability for tetanic noxious stimuli', 'timeFrame': 'Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation', 'description': 'Heart Rate will go up if patient is feeling pain.'}, {'measure': 'The Bispectral Index predictability for tetanic noxious stimuli', 'timeFrame': 'Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation', 'description': 'Bispectral Index will go up if patient is feeling pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '37418059', 'type': 'DERIVED', 'citation': 'Yang L, Wang X, Wen H. Evaluation of the effectiveness of analgesia nociception index (ANI) predictability for surgical stimuli under personal analgesic sufficiency status (PASS) measured by pre-tetanus-induced ANI: a pilot study. J Clin Monit Comput. 2023 Dec;37(6):1585-1591. doi: 10.1007/s10877-023-01044-y. Epub 2023 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'Analgesia Nociception Index（ANI）which is derived from heart rate variability can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.', 'detailedDescription': 'General anesthesia with sevoflurane and remifentanil is widely used in minor surgeries. Monitoring noxious stimulation during general anesthesia is still worth further studies and reaching clinical consensus. Analgesia Nociception Index can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. Previous studies suggest that an ANI≥50 can be useful in detecting sufficient analgesia for patients who cannot self-report pain. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18- 65 years\n* ASA physical status I or II\n* Elective surgery in general anesthesia planned\n* Written informed consent\n\nExclusion Criteria:\n\n* Use of CNS-active medication or abuse of alcohol\n* Presents of any neuromuscular or neurologic disease\n* History of cardiac arrhythmia\n* Pregnancy or using a pacemaker'}, 'identificationModule': {'nctId': 'NCT05063461', 'briefTitle': 'Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane', 'orgStudyIdInfo': {'id': '00375930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevoflurane with different site effect concentrations of remifentanil', 'description': 'The tetanic stimulus is conducted between laryngeal mask intubation and surgical stimulation, while no other noxious stimuli are presented. The effect site concentration of remifentanil is increased step-by-step via a Target Controlled infusion device to a concentration of 2, 4, 6 ng/ml. At least 5min of the steady-state period is maintained before tetanic stimulus.', 'interventionNames': ['Device: Tetanic stimulation', 'Procedure: Skin incision']}], 'interventions': [{'name': 'Tetanic stimulation', 'type': 'DEVICE', 'description': 'For each participant, record the first concentration that ANI≥50 after the tetanic stimuli, as the sufficient concentration.', 'armGroupLabels': ['Sevoflurane with different site effect concentrations of remifentanil']}, {'name': 'Skin incision', 'type': 'PROCEDURE', 'description': 'Infuse the sufficient concentration for at least 5min of the steady-state period, then surgical stimulus is applied. The surgical stimulus is defined as the first skin incision to establish pneumoperitoneum.', 'armGroupLabels': ['Sevoflurane with different site effect concentrations of remifentanil']}]}, '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'}}}}