Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT05322902
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2022-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-17', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative remifentanil consumption (mcg/kg/min)', 'timeFrame': 'Day 0, intraoperative', 'description': 'At the start of anesthesia induction, intravenous remifentanil infusion is started and the intraoperative remifentanil infusion rate is adjusted based on the ANI 50 during surgery. The total dose of remifentanil infused intraoperatively is recorded.'}], 'secondaryOutcomes': [{'measure': 'Numeric rating scale pain score at rest', 'timeFrame': 'up to 24 hours after the surgery', 'description': 'Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 1, 6, 24 hours after the surgery.'}, {'measure': 'Postoperative opioid consumption', 'timeFrame': 'up to 24 hours after the surgery', 'description': 'Postoperative opioid consumption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis', 'Total Knee Arthroplasty', 'Remimazolam']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that intraoperative opioid consumption would be different between remimazolam and propofol if the ANI-guided remifentanil continuous infusion rate was adjusted when the depth of anesthesia was maintained at similar depths with remimazolam or propofol under total intravenous anesthesia. The purpose of this study is to compare the intraoperative remifentanil requirement in patients undergoing total knee arthroplasty when the intraoperative remifentanil dose adjustment was performed under the ANI guidance while maintaining a similar depth of anesthesia with remimazolam or propofol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients 19\\~80 years of age who are expected to elective total knee arthroplasty under general anesthesia\n2. ASA PS 1-3\n\nExclusion Criteria:\n\n1. Second total knee arthroplasty under a prior plan of staged total knee arthroplasty, both\n2. Previous hepatectomy or liver transplant\n3. Estimated glomerular filtration rate \\< 30 mL/min/1.73m2\n4. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)\n5. Uncontrolled hypertension (systolic blood pressure \\> 160mmHg)\n6. Acute narrow angle glaucoma\n7. Myasthesia gravis\n8. Known allergy to the drugs included in the study\n9. Cardiac arrhthmia (non-sinus rhythm)\n10. Taking drugs that affect the autonomic nervous system of diabetes\n11. Psychiatric or neurologic disease (major depression disorder, dementia or cerebral infarction)\n12. History of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT05322902', 'briefTitle': 'Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Comparison of Intraoperative Remifentanil Requirements During Remimazolam Versus Propofol Total Intravenous Anesthesia With Analgesia Nociception Index-guided Remifentanil Administration: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': '3-2022-0039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam group', 'description': 'Total intravenous anesthesia with remimazolam and remifentanil', 'interventionNames': ['Drug: remimazolam group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol group', 'description': 'Total intravenous anesthesia with propofol and remifentanil', 'interventionNames': ['Drug: propofol group']}], 'interventions': [{'name': 'remimazolam group', 'type': 'DRUG', 'description': 'Remimazolam 6 mg/kg/hr is administered as an intravenous infusion until the patient loses consciousness. Anesthesia is maintained at 1 mg/kg/hr of remimazolam. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50.', 'armGroupLabels': ['Remimazolam group']}, {'name': 'propofol group', 'type': 'DRUG', 'description': 'Propofol intravenous infusion is initiated by the application of a target concentration infusion (TCI) pump to cause the patient to lose consciousness. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50.', 'armGroupLabels': ['Propofol group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profeesor', 'investigatorFullName': 'Do-Hyeong Kim', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}