Binaural Sound for Remimazolam Induction

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06099977
• Collaborator: (none)
• Enrollment: 72
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
General Anesthesia; Prostate Cancer; Uterine Myoma	Procedure: Binaural sound; Procedure: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Preoperative Binaural Sound on Remimazolam Dose Required for Induction of General Anesthesia: a Randomized, Placebo-controlled Trial
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2025
• Anticipated Study Completion Date: Oct 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I (Binaural) Binaural sound using headphone will be applied.	Procedure: Binaural sound; Binaural sound: Binaural sound will be applied.
Placebo Comparator: II (Placebo) Only headphone without sound will be applied.	Procedure: Placebo; Only headphone without sound will be applied.

Outcome Measures

Primary Outcome Measures

1. Remimazolam dose for no response to voice [At anesthesia day 0]

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

Secondary Outcome Measures

1. Remimazolam dose for no eye lash reflex [At anesthesia day 0]

   Remimazolam dose for no eye lash reflex will be measured at anesthesia day 0.

2. Remimazolam dose for patient state index 50 [At anesthesia day 0]

   Remimazolam dose for patient state index 50 will be measured at anesthesia day 0.

3. Anxiety level [At anesthesia day 0]

   Anxiety level will be evaluated using viosual analogue scale at anesthesia day 0 (at arrival of preanesthetic room and operating room).

4. Patient state index electroencephalography [At anesthesia day 0]

   Patient state index electroencephalography will be evaluated at anesthesia day 0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients scheduled for generla anesthesia

2. Patients aged 20-60

3. Patients with American Society of Anesthesiologist physical status classification 1-2

4. Patients with ideal body weight 50-80 kg

Exclusion Criteria:

1. Patients with hearing disability

2. Patients using opioids or sedatives in 1 week

3. Patients who are dependent for alcoholics or drugs

4. Patients with hypersensitivities to remimazolam

5. Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia

6. Patients with liver failure

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyun-Chang Kim, Clinical Associate Professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT06099977
• Other Study ID Numbers: 3-2023-0305
• First Posted: Oct 25, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

No Results Posted as of Oct 25, 2023