A Prospective Randomized Controlled Trial on the Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Iowa Satisfaction with Anesthesia Scale(ISAS)
Study Overview
Brief Summary
The investigators will evaluate the effect of bispectral index-guided titration of sedation during ear surgery under monitored anesthesia care on participant's satisfaction with anesthesia, as well as side effects caused by the anesthetics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
The person who surveys the patient's satisfaction in the post anesthesia care unit does not know which group the patient was assigned to.
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients receiving ear surgery with ASA physical status 1 or 2
Exclusion Criteria
- •Age under 19 years
- •Pregnancy
- •Cognitive disorder affecting daily activity
- •Patients who cannot participate in the survey
- •Allergy to the medication
- •History of sedative abuse
Arms & Interventions
OAA/S
The patients in the control group will receive MAC titrated according to observer's assessment of anesthesia/sedation(OAA/S) score.
Intervention: Titration under the guidance of OAA/S (Diagnostic Test)
BIS
The patients in the control group will receive MAC titrated according to bispectral index(BIS).
Intervention: Titration under the guidance of BIS (Device)
Outcomes
Primary Outcomes
Iowa Satisfaction with Anesthesia Scale(ISAS)
Time Frame: within 30 minutes after the end of surgery (in the PACU)
Patient's satisfaction with MAC
Secondary Outcomes
No secondary outcomes reported
Investigators
Ho Geol Ryu
Assistant professor
Seoul National University Hospital