Sedative Adverse ReactionNCT04866433
The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine
A study testing Real-time binaural sound and Music in people with Sedative Adverse Reaction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of the study is to evaluate whether real-time binaural sound affects the dose of dexmedetomidine in patients undergoing sedation with dexmedetomidine after spinal anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Sedative Adverse Reaction
- What is being tested?
- Real-time binaural sound and Music
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 10 Feb 2022
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing sedation with dexmedetomidine during spinal anesthesia for surgery with an estimated time of 90 minutes or longer
Who cannot join
- ASA physical status classification 3-4
- Patients with hearing loss or using hearing aids
- Patients who received narcotic analgesics or sedative drugs within 1 week
- Patients with alcohol dependence or drug dependence
- Patients with drug hypersensitivity to dexmedetomidine
- Patients with arrhythmia, cardiovascular disease, decreased cardiac function and decreased cardiac output
Show all 11Show fewer
- Patients who are judged to be difficult to use sedative drugs due to severe respiratory disease
- Patients with liver failure
- Patients with kidney failure or on dialysis
- Patients judged to be unsuitable for the clinical trial by the researchers
- Patients whose actual operation time is less than 30 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine During Spinal Anesthesia: a Randomized, Placebo-controlled Trial
The aim of the study is to evaluate whether real-time binaural sound affects the dose of dexmedetomidine in patients undergoing sedation with dexmedetomidine after spinal anesthesia.
Read the detailed description
Patients undergoing sedation with dexmedetomidine after spinal anesthesia are randomly assigned to binaural group, audio group, and control group. After spinal anesthesia, SedLine continuous monitoring is started. Real-time binaural sound applied music is played to the binaural group, normal music is played to the audio group, and headphones with no sound are applied to the control group. Observer's Assessment of Alertness/Sedation Scale (OAAS) and Patient State Index (PSi) are checked every minute after loading of dexmedetomidine at the rate of 1 μg/kg for 10 minutes (6 μg/kg/hr). Loading is stopped when the OAAS score is 3 or less. Then, dexmedetomidine is continuously infused at a rate of 0.6 μg/kg/hr, and OAAS is evaluated every 30 minutes. The infusion rate is lowered (-0.1 μg/kg/hr) if OAAS is lower than 3, and increased (+0.1 μg/kg/hr) if OAAS is higher than 3. The continuous infusion rate should not exceed 1 μg/kg/hr. The total dexmedetomidine dose corrected by the patient's predicted body weight and infusion time (μg/kg/hr) was compared between groups. In addition, the loading dose (μg/kg) and continuous infusion dose (μg/kg/hr), additional sedative use, blood pressure, heart rate, ECG changes, respiratory depression, and oxygen saturation were observed. The patient's satisfaction is evaluated after the surgery.
- Conditions
- Sedative Adverse Reaction
- Being tested
- Real-time binaural sound, Music, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time binaural soundProcedure or surgery
Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.
MusicProcedure or surgery
Play the same music in both ears through headphones during sedation
ControlProcedure or surgery
Just wear headphones during sedation
| Study group | Role | What they receive |
|---|---|---|
| Binaural group | Experimental | Play realtime binaural sound applied music through headphones Receives: Procedure: Real-time binaural sound |
| Audio group | Active comparator | Play music through headphones. Receives: Procedure: Music |
| Control group | Sham comparator | Wear headphones that do not produce sound. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)
Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)
Measured: Intraoperative (During sedation for surgery)
Secondary outcomes (8)
Observer's Assessment of Alertness/Sedation Scale (0~5)
Observer's Assessment of Alertness/Sedation Scale (0, does not respond to painful trapezius squeeze; 1, responds only after painful trapezius squeeze; 2, responds only after mild prodding or shaking; 3, responds only after name is called loudly, repeatedly, or both; 4, responds lethargically to name spoken in normal tone; 5, responds readily to name spoken in normal tone)
Measured: During sedation for surgery and at post anesthesia care unit (PACU)
Patient State Index (PSi)
Patient State Index (PSi) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)
Measured: Intraoperative (During sedation for surgery)
Dexmedetomidine continuous infusion dose
Total amount of dexmedetomidine infused from the end of dexmedetomidine loading to the start of suturing the surgical site
Measured: Intraoperative (During sedation for surgery)
Number of patients requiring additional sedatives
Number of patients requiring additional sedatives
Measured: Intraoperative (During sedation for surgery)
Adverse event
Incidence of hypotension, hypertension, bradycardia, ECG change, need of vasopressors, respiratory suppression, desaturation
Measured: Intraoperative (During sedation for surgery)
Patient satisfaction
Patient's satisfaction with intraoperative sedation Score from 0 to 10) with intraoperative sedation measured at the time of leaving the operating room (0~10)
Measured: Intraoperative (At the time of leaving the operating room)
Postanesthesia recovery score (0~10)
Postanesthesia recovery score (0~10, higher scores mean better recovery)
Measured: At the postanesthesia recovery room
Postoperative delirium
Incidence of postoperative delirium
Measured: From the end of the surgery to the hospital discharge, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Jun 2021
- Primary completion27 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedative Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866433
- Sponsor's protocol ID
- 2101-185-1193
- Status last verified
- Feb 2022
- First submitted
- 19 Apr 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bae J, Yoo S, Kim H, Kim Y, Kim JT, Lim YJ, Kim HS. Effect of real-time binaural music on sedation with dexmedetomidine during spinal anesthesia: A triple-arm, assessor-blind, randomized controlled trial. J Clin Anesth. 2023 Feb;84:110997. doi: 10.1016/j.jclinane.2022.110997. Epub 2022 Nov 10.
PubMed 36371942
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine During Spinal Anesthesia: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04866433
- Acronym / sponsor ID
- 2101-185-1193
- Conditions
- Sedative Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 29 Apr 2021 (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.
The aim of the study is to evaluate whether real-time binaural sound affects the dose of dexmedetomidine in patients undergoing sedation with dexmedetomidine after spinal anesthesia.
Detailed description
Patients undergoing sedation with dexmedetomidine after spinal anesthesia are randomly assigned to binaural group, audio group, and control group. After spinal anesthesia, SedLine continuous monitoring is started. Real-time binaural sound applied music is played to the binaural group, normal music is played to the audio group, and headphones with no sound are applied to the control group. Observer's Assessment of Alertness/Sedation Scale (OAAS) and Patient State Index (PSi) are checked every minute after loading of dexmedetomidine at the rate of 1 μg/kg for 10 minutes (6 μg/kg/hr). Loading is stopped when the OAAS score is 3 or less. Then, dexmedetomidine is continuously infused at a rate of 0.6 μg/kg/hr, and OAAS is evaluated every 30 minutes. The infusion rate is lowered (-0.1 μg/kg/hr) if OAAS is lower than 3, and increased (+0.1 μg/kg/hr) if OAAS is higher than 3. The continuous infusion rate should not exceed 1 μg/kg/hr. The total dexmedetomidine dose corrected by the patient's predicted body weight and infusion time (μg/kg/hr) was compared between groups. In addition, the loading dose (μg/kg) and continuous infusion dose (μg/kg/hr), additional sedative use, blood pressure, heart rate, ECG changes, respiratory depression, and oxygen saturation were observed. The patient's satisfaction is evaluated after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Binaural group | Experimental | Procedure: Real-time binaural soundPlay realtime binaural sound applied music through headphones |
| Audio group | Active comparator | Procedure: MusicPlay music through headphones. |
| Control group | Sham comparator | Procedure: ControlWear headphones that do not produce sound. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing sedation with dexmedetomidine during spinal anesthesia for surgery with an estimated time of 90 minutes or longer
Key exclusion criteria (11 listed)
- ASA physical status classification 3-4
- Patients with hearing loss or using hearing aids
- Patients who received narcotic analgesics or sedative drugs within 1 week
- Patients with alcohol dependence or drug dependence
- Patients with drug hypersensitivity to dexmedetomidine
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 |
|---|---|---|
| Real-time binaural soundPlay music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation. | Procedure or surgery | Binaural group |
| MusicPlay the same music in both ears through headphones during sedation | Procedure or surgery | Audio group |
| ControlJust wear headphones during sedation | Procedure or surgery | Control group |
Primary outcome
Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)
Time frame: Intraoperative (During sedation for surgery)
Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)
8 secondary outcomes
Observer's Assessment of Alertness/Sedation Scale (0~5)
Time frame: During sedation for surgery and at post anesthesia care unit (PACU)
Patient State Index (PSi)
Time frame: Intraoperative (During sedation for surgery)
Dexmedetomidine continuous infusion dose
Time frame: Intraoperative (During sedation for surgery)
Number of patients requiring additional sedatives
Time frame: Intraoperative (During sedation for surgery)
Adverse event
Time frame: Intraoperative (During sedation for surgery)
Patient satisfaction
Time frame: Intraoperative (At the time of leaving the operating room)
Postanesthesia recovery score (0~10)
Time frame: At the postanesthesia recovery room
Postoperative delirium
Time frame: From the end of the surgery to the hospital discharge, an average of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 36371942Bae J, Yoo S, Kim H, Kim Y, Kim JT, Lim YJ, Kim HS. Effect of real-time binaural music on sedation with dexmedetomidine during spinal anesthesia: A triple-arm, assessor-blind, randomized controlled trial. J Clin Anesth. 2023 Feb;84:110997. doi: 10.1016/j.jclinane.2022.110997. Epub 2022 Nov 10.
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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.
Hee-Soo Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time binaural sound and Music in people with Sedative Adverse Reaction, run by Seoul National University 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 2 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg) (time frame: Intraoperative (During sedation for surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04866433, which also lists 1 linked publication.
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 2 Mar 2022.