Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Binaural group | Experimental | Play realtime binaural sound applied music through headphones |
|
| Audio group | Active Comparator | Play music through headphones. |
|
| Control group | Sham Comparator | Wear headphones that do not produce sound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-time binaural sound | Procedure | Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg) | Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg) | Intraoperative (During sedation for surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| EEG power in delta band | EEG power in delta band (0.3~4Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA) | During sedation for surgery |
| EEG power in theta band | EEG power in theta band (4~8Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hee-Soo Kim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36371942 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Music | Procedure | Play the same music in both ears through headphones during sedation |
|
| Control | Procedure | Just wear headphones during sedation |
|
| 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) | 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 | Intraoperative (During sedation for surgery) |
| Number of patients requiring additional sedatives | Number of patients requiring additional sedatives | Intraoperative (During sedation for surgery) |
| Adverse event | Incidence of hypotension, hypertension, bradycardia, ECG change, need of vasopressors, respiratory suppression, desaturation | 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) | Intraoperative (At the time of leaving the operating room) |
| Postanesthesia recovery score (0~10) | Postanesthesia recovery score (0~10, higher scores mean better recovery) | At the postanesthesia recovery room |
| Postoperative delirium | Incidence of postoperative delirium | From the end of the surgery to the hospital discharge, an average of 1 week |
| During sedation for surgery |
| EEG power in alpha band | EEG power in alpha band (8~13Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA) | During sedation for surgery |
| EEG power in beta band | EEG power in beta band (13~30Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA) | During sedation for surgery |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |