Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-03 @ 3:05 PM
Study NCT ID:
NCT06432894
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '20 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-06-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemodynamic change', 'timeFrame': 'within 5 minutes of pain stimulus', 'description': 'When there are changes of heart rate or blood pressure more than 20% from baseline within 5 minutes of pain stimulus'}], 'primaryOutcomes': [{'measure': 'ANI values', 'timeFrame': 'During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)', 'description': "A value indicating the degree of pain calculated by ANI's algorithm"}], 'secondaryOutcomes': [{'measure': 'Heart Rate (HR) change', 'timeFrame': 'Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation', 'description': 'Because the ANI value is calculated using the change in HR, it is measured to correlate the change in ANI value with the change in HR due to pain.'}, {'measure': 'Patient state index (PSI) change', 'timeFrame': 'Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation', 'description': "The PSI is an indicator of a patient's depth of sedation and is calculated based on EEG, which can change in response to painful stimuli. The PSI score is expressed as a number between 0 and 100, and it is usually recommended to maintain under 60 during surgery. An increase in the PSI score can indicates the degree of pain stimulus and can be used as an indicator to assess the validity of the ANI value."}, {'measure': 'Blood Pressure change', 'timeFrame': 'Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation', 'description': 'When a patient feels pain, it stimulates the autonomic nervous system to change blood pressure. This change is measured to determine how much pain the patient is feeling'}, {'measure': 'Remimazolam infusion rate', 'timeFrame': 'During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)', 'description': 'Remimazolam is a sedative. The infusion rate of remimazolam correlates with sedation level. And it is measured to determine if sedation level correlates with ANI values when pain stimuli are given.'}, {'measure': 'Effect site concentration of remifentanil', 'timeFrame': 'During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)', 'description': 'Remifentanil is an opioid and can affect pain levels when given a pain stimulus.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remimazolam', 'Remifentanil', 'Analgesia Nociception Index (ANI)'], 'conditions': ['Pain Measurement']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who visit the hospital and undergo surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients\n\n* aged 20-79 years under general anaesthesia with remimazolam\n* scheduled to undergo robotic surgery\n* in American Society of Anesthesiologists physical class 1, 2 or 3\n* voluntarily agree in writing to participate in this clinical study\n\nExclusion Criteria:\n\n* Conditions affecting the autonomic nervous system\n* other conditions or disease that may cause acute or chronic pain\n* the NRS before induction of anesthesia is 1 or over\n* When taking medications that may affect the autonomic nervous system\n* In other cases where the investigator deems the subject unsuitable for this trial'}, 'identificationModule': {'nctId': 'NCT06432894', 'briefTitle': 'Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam', 'organization': {'class': 'OTHER', 'fullName': 'Catholic Kwandong University'}, 'officialTitle': 'Performance Evaluation of Analgesia Nociception Index (ANI) in Patients Under General Anaesthesia With Remimazolam: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Ilsan_Cha_2023-04-003-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observation', 'description': 'Patients\n\n* aged 20-80 years under general anaesthesia with remimazolam\n* scheduled to undergo robotic surgery\n* in American Society of Anesthesiologists physical class 1, 2 or 3', 'interventionNames': ['Combination Product: Analgesia Nociception Index, remimazolam']}], 'interventions': [{'name': 'Analgesia Nociception Index, remimazolam', 'type': 'COMBINATION_PRODUCT', 'description': "The purpose of this study is to determine the validity of ANI in patients undergoing surgery with remifentanil and remimazolam.\n\nDuring this study, remimazolam infusion rate is determined by the pharmacopoeia.\n\nRemifentanil infusion rate is determined based on the patient's vital signs, systemic status and pain levels. And remifentanil is administrated via targeted infusion control using the Minto model.\n\nANI scores, vital signs, remifentanil infusion rate are collected at predetermined time points according to the protocol from the start to the end of the surgery.", 'armGroupLabels': ['observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22711', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jungmin Lee, MD', 'role': 'CONTACT', 'email': 'jminyi19@gmail.com', 'phone': '821041929159'}, {'name': 'Joohyun Lee, MD', 'role': 'CONTACT', 'email': 'hightothesky1004@gmail.com', 'phone': '821074200912'}], 'facility': 'Catholic-Kwandong University, School of Medicine', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Jungmin Lee', 'role': 'CONTACT', 'email': 'jminyi19@gmail.com', 'phone': '821041929159'}, {'name': 'Joohyun Lee', 'role': 'CONTACT', 'email': 'hightothesky1004@gmail.com', 'phone': '821074200912'}], 'overallOfficials': [{'name': 'Young Joo', 'role': 'STUDY_CHAIR', 'affiliation': 'Ilsan Cha hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic Kwandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jungmin Lee', 'investigatorAffiliation': 'Catholic Kwandong University'}}}}