Binaural Sound for Remimazolam Induction
Primary Purpose
General Anesthesia, Prostate Cancer, Uterine Myoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Binaural sound
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for General Anesthesia
Eligibility Criteria
Inclusion Criteria: 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 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 Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia Patients with liver failure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
I (Binaural)
II (Placebo)
Arm Description
Binaural sound using headphone will be applied.
Only headphone without sound will be applied.
Outcomes
Primary Outcome Measures
Remimazolam dose for no response to voice
Remimazolam dose for no response to voice will be measured at anesthesia day 0.
Secondary Outcome Measures
Remimazolam dose for no eye lash reflex
Remimazolam dose for no eye lash reflex will be measured at anesthesia day 0.
Remimazolam dose for patient state index 50
Remimazolam dose for patient state index 50 will be measured at anesthesia day 0.
Anxiety level
Anxiety level will be evaluated using viosual analogue scale at anesthesia day 0 (at arrival of preanesthetic room and operating room).
Patient state index electroencephalography
Patient state index electroencephalography will be evaluated at anesthesia day 0
Full Information
NCT ID
NCT06099977
First Posted
October 20, 2023
Last Updated
October 20, 2023
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06099977
Brief Title
Binaural Sound for Remimazolam Induction
Official Title
The Effect of Preoperative Binaural Sound on Remimazolam Dose Required for Induction of General Anesthesia: a Randomized, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthesia, Prostate Cancer, Uterine Myoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I (Binaural)
Arm Type
Experimental
Arm Description
Binaural sound using headphone will be applied.
Arm Title
II (Placebo)
Arm Type
Placebo Comparator
Arm Description
Only headphone without sound will be applied.
Intervention Type
Procedure
Intervention Name(s)
Binaural sound
Intervention Description
Binaural sound: Binaural sound will be applied.
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Only headphone without sound will be applied.
Primary Outcome Measure Information:
Title
Remimazolam dose for no response to voice
Description
Remimazolam dose for no response to voice will be measured at anesthesia day 0.
Time Frame
At anesthesia day 0
Secondary Outcome Measure Information:
Title
Remimazolam dose for no eye lash reflex
Description
Remimazolam dose for no eye lash reflex will be measured at anesthesia day 0.
Time Frame
At anesthesia day 0
Title
Remimazolam dose for patient state index 50
Description
Remimazolam dose for patient state index 50 will be measured at anesthesia day 0.
Time Frame
At anesthesia day 0
Title
Anxiety level
Description
Anxiety level will be evaluated using viosual analogue scale at anesthesia day 0 (at arrival of preanesthetic room and operating room).
Time Frame
At anesthesia day 0
Title
Patient state index electroencephalography
Description
Patient state index electroencephalography will be evaluated at anesthesia day 0
Time Frame
At anesthesia day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
Patients with liver failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Chang Kim
Phone
82-2-2224-3919
Email
onidori@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Binaural Sound for Remimazolam Induction
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