General AnesthesiaNCT06497283
Binaural Sound for Remimazolam Maintenance
A study testing Binaural sound in people with General Anesthesia and Prostate Cancer Stage, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- General Anesthesia, Prostate Cancer Stage, Uterine Myoma
- What is being tested?
- Binaural sound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul
Hyun Chang Kim, 82-2-2019-4601
About this study
Official title: The Effect of Intraoperative Binaural Sound on Remifentanil Dose Required for General Anesthesia Using Remimazolam: a Randomized, Placebo-controlled Trial
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.
- Conditions
- General Anesthesia, Prostate Cancer Stage, Uterine Myoma
- Being tested
- Binaural sound
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural soundProcedure or surgery
Binaural sound: Binaural sound will be applied.
| Study group | Role | What they receive |
|---|---|---|
| I (Binaural) | Experimental | Binaural sound using earphone will be applied. Receives: Procedure: Binaural sound |
| II (Placebo) | Placebo comparator | Only headphone without sound will be applied. Receives: Procedure: Binaural sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil dose
Intraoperative remifentanil dose will be measured at anesthesia day 0.
Measured: At anesthesia day 0
Secondary outcomes (3)
Intraoperative remimazolam dose
Intraoperative remimazolam dose will be measured at anesthesia day 0.
Measured: At anesthesia day 0
Pain score (0:no pain, 10:maximal pain)
Pain score (0:no pain, 10:maximal pain) will be measured at anesthesia day 0 and 1.
Measured: At anesthesia day 0 and 1
Electroencephalography
The relative power of alpha, beta, delta, gamma, and theta band in electroencephalography will be measured at anesthesia day 0.
Measured: At anesthesia day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start12 Jul 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Chang Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497283
- Sponsor's protocol ID
- 3-2024-0171
- Status last verified
- Aug 2024
- First submitted
- 3 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Binaural Sound on Remifentanil Dose Required for General Anesthesia Using Remimazolam: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06497283
- Acronym / sponsor ID
- 3-2024-0171
- Conditions
- General Anesthesia, Prostate Cancer Stage, Uterine Myoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I (Binaural) | Experimental | Procedure: Binaural soundBinaural sound using earphone will be applied. |
| II (Placebo) | Placebo comparator | Procedure: Binaural soundOnly headphone without sound will be applied. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binaural soundBinaural sound: Binaural sound will be applied. | Procedure or surgery | I (Binaural), II (Placebo) |
Primary outcome
Intraoperative remifentanil dose
Time frame: At anesthesia day 0
Intraoperative remifentanil dose will be measured at anesthesia day 0.
3 secondary outcomes
Intraoperative remimazolam dose
Time frame: At anesthesia day 0
Pain score (0:no pain, 10:maximal pain)
Time frame: At anesthesia day 0 and 1
Electroencephalography
Time frame: At anesthesia day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural sound in people with General Anesthesia and Prostate Cancer Stage, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Chang Kim (0220194601, gsirb@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative remifentanil dose (time frame: At anesthesia day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.