Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-03-14 @ 5:38 AM
Study NCT ID:
NCT05432050
Status:
UNKNOWN
Last Update Posted:
2022-07-01
First Post:
2022-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bispectral Index and Patient State Index During General Anesthesia With Remimazolam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2022-06-20', 'studyFirstSubmitQcDate': '2022-06-20', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of time when bispectral index (BIS) was < 60', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'The percentage of time when BIS was \\< 60 (divided by the time between the loss of consciousness during induction of anesthesia and the full awakening during emergence from anesthesia.)'}, {'measure': 'The percentage of time when patient state index (PSI) was < 50', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'The percentage of time when PSI was \\< 50 (divided by the time between the loss of consciousness during induction of anesthesia and the full awakening during emergence from anesthesia.)'}], 'secondaryOutcomes': [{'measure': 'Heart rate (bpm)', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'Heart rate (bpm) measured before induction of anesthesia, at loss of consciousness, and before transfer to post-anesthesia care unit.'}, {'measure': 'blood pressure (mmHg)', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'blood pressure (mmHg) measured before induction of anesthesia, at loss of consciousness, and before transfer to post-anesthesia care unit.'}, {'measure': 'Bispectral index (BIS) during anesthesia', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'Bispectral index (BIS) is continuously recorded during anesthesia.'}, {'measure': 'Patient state index (PSI) during anesthesia', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'Patient state index (PSI) is continuously recorded during anesthesia.'}, {'measure': 'The percentage of time when bispectral index (BIS) was < 60, and > 40.', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'The percentage of time when BIS was \\< 60, and \\> 40 (divided by the time between the loss of consciousness during induction of anesthesia and the full awakening during emergence from anesthesia.)'}, {'measure': 'The percentage of time when patient state index (PSI) was < 50, and > 25.', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'The percentage of time when PSI was \\< 50, and \\> 25 (divided by the time between the loss of consciousness during induction of anesthesia and the full awakening during emergence from anesthesia.)'}, {'measure': 'The last number patient remember that he/she spoke during induction of anesthesia', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'The last number patient remember that he/she spoke during induction of anesthesia (begin from 1 to loss of consciousness)'}, {'measure': 'Remimazolam infusion history', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'The rate of Remimazolam infusion is recorded during anesthesia.'}, {'measure': 'Remifentanil infusion history', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'The target effect-site concentration of remifentanil infusion is recorded during anesthesia.'}, {'measure': 'Total amount of remimazolam used (mg/kg/h)', 'timeFrame': 'During anesthesia (up to 6hours)', 'description': 'Total amount of remimazolam used (mg/kg/h) during anesthesia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient state index', 'Bispectral index', 'Electroencephalography'], 'conditions': ['Remimazolam', 'Anesthesia, General', 'Hypnotics and Sedatives', 'Thyroid Disease', 'Breast Diseases', 'Parathyroid Diseases']}, 'referencesModule': {'references': [{'pmid': '33965206', 'type': 'BACKGROUND', 'citation': 'Sneyd JR, Gambus PL, Rigby-Jones AE. Current status of perioperative hypnotics, role of benzodiazepines, and the case for remimazolam: a narrative review. Br J Anaesth. 2021 Jul;127(1):41-55. doi: 10.1016/j.bja.2021.03.028. Epub 2021 May 6.'}, {'pmid': '32157465', 'type': 'BACKGROUND', 'citation': 'Masui K. Remimazolam besilate, a benzodiazepine, has been approved for general anesthesia!! J Anesth. 2020 Aug;34(4):479-482. doi: 10.1007/s00540-020-02755-1. Epub 2020 Mar 10. No abstract available.'}, {'pmid': '32530890', 'type': 'BACKGROUND', 'citation': 'Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877.'}, {'pmid': '31972655', 'type': 'BACKGROUND', 'citation': 'Schuttler J, Eisenried A, Lerch M, Fechner J, Jeleazcov C, Ihmsen H. Pharmacokinetics and Pharmacodynamics of Remimazolam (CNS 7056) after Continuous Infusion in Healthy Male Volunteers: Part I. Pharmacokinetics and Clinical Pharmacodynamics. Anesthesiology. 2020 Apr;132(4):636-651. doi: 10.1097/ALN.0000000000003103.'}, {'pmid': '22190555', 'type': 'BACKGROUND', 'citation': 'Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the bispectral index (BIS) and patient state index (PSI) during general anesthesia using remimazolam. The infusion rate of remimazolam is 6-12mg/kg/h during induction of anesthesia and 1-2mg/kg/h during maintenance of anesthesia. To calculate the fraction, the sum of times when BIS\\<60 and PSI \\<50 will be divided by the time from the loss of consciousness during induction of anesthesia to fully awake during emergence. We will compare the fraction of BIS \\<60 and the fraction of PSI \\<50 to find if there is some difference between the two depth of anesthesia monitoring devices during remimazolam anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients (ASA class I,II) who need general anesthesia for surger', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 19 years need general anesthesia\n* American Society of Anesthesiologists (ASA) Classification I, II\n* Written informed consent\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) Classification III, IV, V\n* BMI \\> 40kg/m\\^2\n* Past medical history of anaphylactic reaction to remimazolam, remifentanil, or other benzodiazepines.\n* Administration of anxiolytics, antipsychotics, rifampicin, succinylcholine, neostigmine, flumazenil, and cyclosporin within the past 24 hours\n* Benzodiazepine user (e.g. for seizure control)\n* Transfer to intensive care unit after surgery'}, 'identificationModule': {'nctId': 'NCT05432050', 'briefTitle': 'Bispectral Index and Patient State Index During General Anesthesia With Remimazolam', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Bispectral Index and Patient State Index During General Anesthesia With Remimazolam: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'H-2204-008-1313'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Remimazolam anesthesia', 'description': 'General anesthesia will be induced and maintained by remimazolam and the depth of anesthesia will be monitored with both the bispectral index and patient state index at the same time.', 'interventionNames': ['Device: Bispectral index and Patient state index monitoring']}], 'interventions': [{'name': 'Bispectral index and Patient state index monitoring', 'type': 'DEVICE', 'description': 'The depth of anesthesia will be monitored with both the bispectral index and patient state index at the same time.', 'armGroupLabels': ['Remimazolam anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Hee-Soo Kim, MD.PhD', 'role': 'CONTACT', 'email': 'dami0605@snu.ac.kr', 'phone': '08201052878006'}, {'name': 'Young-Eun Jang, MD. PhD', 'role': 'CONTACT', 'email': 'na0ag2@hotmail.com', 'phone': '08201094872233'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Young-Eun Jang, MD,PhD', 'role': 'CONTACT', 'email': 'na0ag2@hotmail.com', 'phone': '082-010-9487-2233'}], 'overallOfficials': [{'name': 'Hee-Soo Kim, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hee-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}