Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-01 @ 12:36 AM
Study NCT ID:
NCT04866433
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2021-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-04-26', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'EEG power in delta band', 'timeFrame': 'During sedation for surgery', 'description': 'EEG power in delta band (0.3\\~4Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)'}, {'measure': 'EEG power in theta band', 'timeFrame': 'During sedation for surgery', 'description': 'EEG power in theta band (4\\~8Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)'}, {'measure': 'EEG power in alpha band', 'timeFrame': 'During sedation for surgery', 'description': 'EEG power in alpha band (8\\~13Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)'}, {'measure': 'EEG power in beta band', 'timeFrame': 'During sedation for surgery', 'description': 'EEG power in beta band (13\\~30Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)'}], 'primaryOutcomes': [{'measure': 'Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)', 'timeFrame': 'Intraoperative (During sedation for surgery)', 'description': 'Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)'}], 'secondaryOutcomes': [{'measure': "Observer's Assessment of Alertness/Sedation Scale (0~5)", 'timeFrame': 'During sedation for surgery and at post anesthesia care unit (PACU)', 'description': "Observer's Assessment of Alertness/Sedation Scale (0, does not respond to painful trapezius squeeze; 1, responds only after painful trapezius squeeze; 2, responds only after mild prodding or shaking; 3, responds only after name is called loudly, repeatedly, or both; 4, responds lethargically to name spoken in normal tone; 5, responds readily to name spoken in normal tone)"}, {'measure': 'Patient State Index (PSi)', 'timeFrame': 'Intraoperative (During sedation for surgery)', 'description': 'Patient State Index (PSi) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)'}, {'measure': 'Dexmedetomidine continuous infusion dose', 'timeFrame': 'Intraoperative (During sedation for surgery)', 'description': 'Total amount of dexmedetomidine infused from the end of dexmedetomidine loading to the start of suturing the surgical site'}, {'measure': 'Number of patients requiring additional sedatives', 'timeFrame': 'Intraoperative (During sedation for surgery)', 'description': 'Number of patients requiring additional sedatives'}, {'measure': 'Adverse event', 'timeFrame': 'Intraoperative (During sedation for surgery)', 'description': 'Incidence of hypotension, hypertension, bradycardia, ECG change, need of vasopressors, respiratory suppression, desaturation'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Intraoperative (At the time of leaving the operating room)', 'description': "Patient's satisfaction with intraoperative sedation Score from 0 to 10) with intraoperative sedation measured at the time of leaving the operating room (0\\~10)"}, {'measure': 'Postanesthesia recovery score (0~10)', 'timeFrame': 'At the postanesthesia recovery room', 'description': 'Postanesthesia recovery score (0\\~10, higher scores mean better recovery)'}, {'measure': 'Postoperative delirium', 'timeFrame': 'From the end of the surgery to the hospital discharge, an average of 1 week', 'description': 'Incidence of postoperative delirium'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedative Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '36371942', 'type': 'DERIVED', 'citation': 'Bae J, Yoo S, Kim H, Kim Y, Kim JT, Lim YJ, Kim HS. Effect of real-time binaural music on sedation with dexmedetomidine during spinal anesthesia: A triple-arm, assessor-blind, randomized controlled trial. J Clin Anesth. 2023 Feb;84:110997. doi: 10.1016/j.jclinane.2022.110997. Epub 2022 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate whether real-time binaural sound affects the dose of dexmedetomidine in patients undergoing sedation with dexmedetomidine after spinal anesthesia.', 'detailedDescription': "Patients undergoing sedation with dexmedetomidine after spinal anesthesia are randomly assigned to binaural group, audio group, and control group. After spinal anesthesia, SedLine continuous monitoring is started. Real-time binaural sound applied music is played to the binaural group, normal music is played to the audio group, and headphones with no sound are applied to the control group. Observer's Assessment of Alertness/Sedation Scale (OAAS) and Patient State Index (PSi) are checked every minute after loading of dexmedetomidine at the rate of 1 μg/kg for 10 minutes (6 μg/kg/hr). Loading is stopped when the OAAS score is 3 or less. Then, dexmedetomidine is continuously infused at a rate of 0.6 μg/kg/hr, and OAAS is evaluated every 30 minutes. The infusion rate is lowered (-0.1 μg/kg/hr) if OAAS is lower than 3, and increased (+0.1 μg/kg/hr) if OAAS is higher than 3. The continuous infusion rate should not exceed 1 μg/kg/hr. The total dexmedetomidine dose corrected by the patient's predicted body weight and infusion time (μg/kg/hr) was compared between groups. In addition, the loading dose (μg/kg) and continuous infusion dose (μg/kg/hr), additional sedative use, blood pressure, heart rate, ECG changes, respiratory depression, and oxygen saturation were observed. The patient's satisfaction is evaluated after the surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing sedation with dexmedetomidine during spinal anesthesia for surgery with an estimated time of 90 minutes or longer\n\nExclusion Criteria:\n\n* ASA physical status classification 3-4\n* Patients with hearing loss or using hearing aids\n* Patients who received narcotic analgesics or sedative drugs within 1 week\n* Patients with alcohol dependence or drug dependence\n* Patients with drug hypersensitivity to dexmedetomidine\n* Patients with arrhythmia, cardiovascular disease, decreased cardiac function and decreased cardiac output\n* Patients who are judged to be difficult to use sedative drugs due to severe respiratory disease\n* Patients with liver failure\n* Patients with kidney failure or on dialysis\n* Patients judged to be unsuitable for the clinical trial by the researchers\n* Patients whose actual operation time is less than 30 minutes'}, 'identificationModule': {'nctId': 'NCT04866433', 'briefTitle': 'The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine During Spinal Anesthesia: a Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '2101-185-1193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Binaural group', 'description': 'Play realtime binaural sound applied music through headphones', 'interventionNames': ['Procedure: Real-time binaural sound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Audio group', 'description': 'Play music through headphones.', 'interventionNames': ['Procedure: Music']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Wear headphones that do not produce sound.', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'Real-time binaural sound', 'type': 'PROCEDURE', 'description': 'Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.', 'armGroupLabels': ['Binaural group']}, {'name': 'Music', 'type': 'PROCEDURE', 'description': 'Play the same music in both ears through headphones during sedation', 'armGroupLabels': ['Audio group']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'Just wear headphones during sedation', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hee-Soo Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hee-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}