NCT06497283

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 3, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

July 12, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

July 3, 2024

Last Update Submit

August 7, 2024

Conditions

General AnesthesiaProstate Cancer StageUterine Myoma

Outcome Measures

Primary Outcomes (1)

  • Intraoperative remifentanil dose

    Intraoperative remifentanil dose will be measured at anesthesia day 0.

    At anesthesia day 0

Secondary Outcomes (3)

  • Intraoperative remimazolam dose

    At anesthesia day 0

  • Pain score (0:no pain, 10:maximal pain)

    At anesthesia day 0 and 1

  • Electroencephalography

    At anesthesia day 0

Study Arms (2)

I (Binaural)

EXPERIMENTAL

Binaural sound using earphone will be applied.

Procedure: Binaural sound

II (Placebo)

PLACEBO COMPARATOR

Only headphone without sound will be applied.

Procedure: Binaural sound

Interventions

Binaural soundPROCEDURE

Binaural sound: Binaural sound will be applied.

I (Binaural)II (Placebo)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Hyun-Chang Kim

CONTACT

0220194601gsirb@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 11, 2024

Study Start

July 12, 2024

Primary Completion

February 1, 2025

Study Completion

February 28, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations

KR(1)