Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT05423951
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2022-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in OPCAB Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007275', 'term': 'Injections, Intravenous'}, {'id': 'D011208', 'term': 'Powders'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D061605', 'term': 'Administration, Intravenous'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2022-06-12', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MAP-time integral', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'The area under the baseline MAP (sec \\* mmHg). Baseline MAP was defined as the mean MAP over the 3 min period immediately before induction.'}], 'secondaryOutcomes': [{'measure': 'Time to loss of consciousness', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'The time from the study drug administration to loss of consciousness'}, {'measure': 'Mean blood pressure', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'maximum / minimum value (mmHg)'}, {'measure': 'Heart rate', 'timeFrame': 'During 10 minute from the administration of remimazolam or propofol', 'description': 'maximum / minimum / mean / median / time-weighted average values (bpm)'}, {'measure': 'Regional cerebral oxygen saturation', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'continuous monitoring of regional cerebral oxygen saturation during surgery (%)'}, {'measure': 'Cardiac output', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'continuous monitoring of cardiac output (L/min)'}, {'measure': 'Sufentanil dose', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'Total dose of administered sufentanil (mcg)'}, {'measure': 'Crystalloid', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'Total volume of administered crystalloid (ml)'}, {'measure': 'Study drug dose', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'Total dose of administered remimazolam or propofol (mg)'}, {'measure': 'Number of vasopressor administration', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': '1. Total number (n)\n2. Ephedrine (n)\n3. Phenylephrine (n)\n4. Vasopressin (n)\n5. Norepinephrine (n)'}, {'measure': 'Ephedrine dose', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'Total dose of administered ephedrine (mg)'}, {'measure': 'Phenylephrine dose', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'Total dose of administered phenylephrine (mcg)'}, {'measure': 'Vasopressin dose', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'Total dose of administered vasopressin (unit) 2. Ephedrine: total dose / number of administration 3. Phenylephrine: total dose / number of administration 4. Vasopressin: total dose / number of administration 5. Norepinephrine: total dose / number of administration'}, {'measure': 'Norepinephrine dose', 'timeFrame': 'During 10 minute from the administration of the study drug', 'description': 'Total dose of administered norepinephrine (mcg)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemodynamics', 'remimazolam', 'propofol', 'coronary artery bypass grafting'], 'conditions': ['Hemodynamic Instability']}, 'descriptionModule': {'briefSummary': 'Remimazolam is a novel ultra-short-acting benzodiazepine. Several studies demonstrated that its efficacy as a sedative hypnotics for general anesthesia is non-inferior to propofol. However, evidence on the hemodynamic stability of remimazolam for the anesthesia induction in patients undergoing coronary artery bypass grafting is lacking. This prospective randomized trial aims to compare hemodynamic stability during anesthesia induction between remimazolam and propofol in patients undergoing coronary artery bypass grafting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (aged 19 years or older) who scheduled for elective coronary artery bypass grafting\n\nExclusion Criteria:\n\n* Patients who refuse to participate\n* Concomitant heart valve surgery or thoracic aorta surgery\n* Emergent surgery\n* Preoperative sedation\n* Intubated state\n* Patients with mechanical circulatory assist device\n* Preoperative use of inotropes or vasopressors\n* History of allergy or adverse reaction to study drugs\n* Rapid sequence intubation\n* Lactose intolerance\n* Peanut allergy'}, 'identificationModule': {'nctId': 'NCT05423951', 'briefTitle': 'Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in OPCAB Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in Patients Undergoing Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'Remimazolam_OPCAB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam', 'interventionNames': ['Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]', 'Drug: Rocuronium', 'Drug: Sufentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'interventionNames': ['Drug: Propofol', 'Drug: Rocuronium', 'Drug: Sufentanil']}], 'interventions': [{'name': 'REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]', 'type': 'DRUG', 'otherNames': ['Remimazolam Besylate'], 'description': 'For the induction of anesthesia, patients allocated to the remimazolam group will receive intravenous infusion of remimazolam at a rate of 6 mg/kg/h, followed by 1 mg/kg/h after the loss of consciousness. The infusion rate of remimazolam will be adjusted to a maximum rate of 2 mg/kg/h to achieve a bispectral index of 40 to 60.', 'armGroupLabels': ['Remimazolam']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'For the induction of anesthesia, patients allocated to the propofol group will receive a bolus dose of propofol 1.5 mg/kg. After the loss of consciousness, general anesthesia will be maintained with sevoflurane to achieve a bispectral index of 40 to 60.', 'armGroupLabels': ['Propofol']}, {'name': 'Rocuronium', 'type': 'DRUG', 'description': 'After the loss of consciousness, a bolus of rocuronium 1 mg/kg was intravenously administered. After 90 seconds of manual ventilation, endotracheal intubation was performed', 'armGroupLabels': ['Propofol', 'Remimazolam']}, {'name': 'Sufentanil', 'type': 'DRUG', 'description': "During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.", 'armGroupLabels': ['Propofol', 'Remimazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yunseok Jeon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yunseok Jeon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}