Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04866433
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2021-04-19
Brief Title:
The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine During Spinal Anesthesia a Randomized Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Observers Assessment of AlertnessSedation Scale OAAS and Patient State Index PSi are checked every minute after loading of dexmedetomidine at the rate of 1 μgkg for 10 minutes 6 μgkghr Loading is stopped when the OAAS score is 3 or less Then dexmedetomidine is continuously infused at a rate of 06 μgkghr and OAAS is evaluated every 30 minutes The infusion rate is lowered -01 μgkghr if OAAS is lower than 3 and increased 01 μgkghr if OAAS is higher than 3 The continuous infusion rate should not exceed 1 μgkghr The total dexmedetomidine dose corrected by the patients predicted body weight and infusion time μgkghr was compared between groups In addition the loading dose μgkg and continuous infusion dose μgkghr additional sedative use blood pressure heart rate ECG changes respiratory depression and oxygen saturation were observed The patients satisfaction is evaluated after the surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None