NCT04866433

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

April 19, 2021

Last Update Submit

February 14, 2022

Conditions

Sedative Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)

    Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)

    Intraoperative (During sedation for surgery)

Secondary Outcomes (8)

  • Observer's Assessment of Alertness/Sedation Scale (0~5)

    During sedation for surgery and at post anesthesia care unit (PACU)

  • Patient State Index (PSi)

    Intraoperative (During sedation for surgery)

  • Dexmedetomidine continuous infusion dose

    Intraoperative (During sedation for surgery)

  • Number of patients requiring additional sedatives

    Intraoperative (During sedation for surgery)

  • Adverse event

    Intraoperative (During sedation for surgery)

  • +3 more secondary outcomes

Other Outcomes (4)

  • EEG power in delta band

    During sedation for surgery

  • EEG power in theta band

    During sedation for surgery

  • EEG power in alpha band

    During sedation for surgery

  • +1 more other outcomes

Study Arms (3)

Binaural group

EXPERIMENTAL

Play realtime binaural sound applied music through headphones

Procedure: Real-time binaural sound

Audio group

ACTIVE COMPARATOR

Play music through headphones.

Procedure: Music

Control group

SHAM COMPARATOR

Wear headphones that do not produce sound.

Procedure: Control

Interventions

Real-time binaural soundPROCEDURE

Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.

Binaural group
MusicPROCEDURE

Play the same music in both ears through headphones during sedation

Audio group
ControlPROCEDURE

Just wear headphones during sedation

Control group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing sedation with dexmedetomidine during spinal anesthesia for surgery with an estimated time of 90 minutes or longer

You may not qualify if:

  • ASA physical status classification 3-4
  • Patients with hearing loss or using hearing aids
  • Patients who received narcotic analgesics or sedative drugs within 1 week
  • Patients with alcohol dependence or drug dependence
  • Patients with drug hypersensitivity to dexmedetomidine
  • Patients with arrhythmia, cardiovascular disease, decreased cardiac function and decreased cardiac output
  • Patients who are judged to be difficult to use sedative drugs due to severe respiratory disease
  • Patients with liver failure
  • Patients with kidney failure or on dialysis
  • Patients judged to be unsuitable for the clinical trial by the researchers
  • Patients whose actual operation time is less than 30 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 36371942DERIVED

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hee-Soo Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 29, 2021

Study Start

June 1, 2021

Primary Completion

January 27, 2022

Study Completion

February 10, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

KR(1)