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Clinical Trials/NCT06497283
NCT06497283
Recruiting
N/A

The Effect of Intraoperative Binaural Sound on Remifentanil Dose Required for General Anesthesia Using Remimazolam: a Randomized, Placebo-controlled Trial

Gangnam Severance Hospital1 site in 1 country72 target enrollmentJuly 12, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
General Anesthesia
Sponsor
Gangnam Severance Hospital
Enrollment
72
Locations
1
Primary Endpoint
Intraoperative remifentanil dose
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

It is important to decrease the remifentanil dose for general anesthesia maintenance when using remimazolam. We will evaluate the effect of binaural sound on general anesthesia maintenance with remimazolam infusion.

Registry
clinicaltrials.gov
Start Date
July 12, 2024
End Date
February 28, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyun-Chang Kim

Associate Professor

Gangnam Severance Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for general anesthesia
  • Patients aged 20-60
  • Patients with American Society of Anesthesiologist physical status classification 1-2
  • Patients with ideal body weight 50-80 kg

Exclusion Criteria

  • Patients with hearing disability
  • Patients using opioids or sedatives in 1 week
  • Patients who are dependent for alcoholics or drugs
  • Patients with hypersensitivities to remimazolam or remifentanil
  • Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
  • Patients with liver failure

Outcomes

Primary Outcomes

Intraoperative remifentanil dose

Time Frame: At anesthesia day 0

Intraoperative remifentanil dose will be measured at anesthesia day 0.

Secondary Outcomes

  • Intraoperative remimazolam dose(At anesthesia day 0)
  • Electroencephalography(At anesthesia day 0)
  • Pain score (0:no pain, 10:maximal pain)(At anesthesia day 0 and 1)

Study Sites (1)

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