NCT06099977

Brief Summary

It is important to decrease the time-to-loss of consciousness and anesthetics dose of remimazolam for general anesthesia induction. We will evaluate the effect of binaural sound for general anestheia induction using remimazolam infusion.

Trial Health

43
At Risk

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 Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

October 20, 2023

Last Update Submit

November 17, 2023

Conditions

General AnesthesiaProstate CancerUterine Myoma

Outcome Measures

Primary Outcomes (1)

  • Remimazolam dose for no response to voice

    Remimazolam dose for no response to voice will be measured at anesthesia day 0.

    At anesthesia day 0

Secondary Outcomes (4)

  • Remimazolam dose for no eye lash reflex

    At anesthesia day 0

  • Remimazolam dose for patient state index 50

    At anesthesia day 0

  • Anxiety level

    At anesthesia day 0

  • Patient state index electroencephalography

    At anesthesia day 0

Study Arms (2)

I (Binaural)

EXPERIMENTAL

Binaural sound using headphone will be applied.

Procedure: Binaural sound

II (Placebo)

PLACEBO COMPARATOR

Only headphone without sound will be applied.

Procedure: Placebo

Interventions

Binaural soundPROCEDURE

Binaural sound: Binaural sound will be applied.

I (Binaural)
PlaceboPROCEDURE

Only headphone without sound will be applied.

II (Placebo)

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for generla 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
  • 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)

GangnamSeveranceHospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsMyofibroma

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeConnective Tissue DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Hyun-Chang Kim

CONTACT

82-2-2224-3919onidori@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
Clinical Associate Professor

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 25, 2023

Study Start

November 1, 2023

Primary Completion

October 1, 2025

Study Completion

October 30, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

KR(1)