Status:

COMPLETED

The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine

Lead Sponsor:

Seoul National University Hospital

Conditions:

Sedative Adverse Reaction

Eligibility:

All Genders

19-80 years

Phase:

NA

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.

Detailed Description

Patients undergoing sedation with dexmedetomidine after spinal anesthesia are randomly assigned to binaural group, audio group, and control group. After spinal anesthesia, SedLine continuous monitorin...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

June 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 10 2022

Estimated Enrollment :

189 Patients enrolled

Trial Details

Trial ID

NCT04866433

Start Date

June 1 2021

End Date

February 10 2022

Last Update

March 2 2022

Active Locations (1)

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Seoul National University Hospital

Seoul, South Korea, 03080