Verbal Stimulation of Orientation on Emergence Agitation
NCT ID: NCT05105178
Last Updated: 2022-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2021-11-09
2022-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Orientation
Information of orientation (time, place, patient's own name) is repeatedly provided during emergence.
Giving orientation with headphones
During emergence, recorded voice of an investigator giving Information of orientation (time, place, patient's own name) is repeatedly played from noise-cancelling headphones
Name
As usual, patient is recovered from general anesthesia with his/her name called.
Emergence as usual with headphones
During emergence, recorded voice of an investigator calling the patient's name is repeatedly played from noise-cancelling headphones
Interventions
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Giving orientation with headphones
During emergence, recorded voice of an investigator giving Information of orientation (time, place, patient's own name) is repeatedly played from noise-cancelling headphones
Emergence as usual with headphones
During emergence, recorded voice of an investigator calling the patient's name is repeatedly played from noise-cancelling headphones
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Change in operation schedule
* American Society of Anaesthesiologists (ASA) physical status Ⅳ
* Day surgery
* BMI ≥35
* Neurocognitive impairment, hearing disorder
* Psychological drug intake
* Experience of general anesthesia or sedation within 1 month
Drop out Criteria
* Changes in operation schedule (e.g. unexpected collaborative surgery, conversion to laparotomy, delay of the schedule to night-duty hours)
* Significant protocol violation
18 Years
70 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Bo Rim Kim
Clinical assistant professor
Principal Investigators
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Bo Rim Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Lee S, Sohn JY, Hwang IE, Lee HJ, Yoon S, Bahk JH, Kim BR. Effect of a repeated verbal reminder of orientation on emergence agitation after general anaesthesia for minimally invasive abdominal surgery: a randomised controlled trial. Br J Anaesth. 2023 Apr;130(4):439-445. doi: 10.1016/j.bja.2022.12.009. Epub 2023 Jan 23.
Other Identifiers
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21082521254
Identifier Type: -
Identifier Source: org_study_id
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