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Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care

A Prospective Randomized Controlled Trial on the Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03410082
Acronym
BISMAC
Enrollment
31
Registered
2018-01-25
Start date
2017-08-15
Completion date
2019-03-30
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bispectral Index, Monitored Anesthesia Care

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.

Interventions

DEVICETitration under the guidance of BIS

The infusion rate of dexmedetomidine is increased by 0.1mcg/kg/h if BIS is greater than 80; The infusion rate is decreased by 0.1mcg/kg/h if BIS is less than 60.

DIAGNOSTIC_TESTTitration under the guidance of OAA/S

The infusion rate of dexmedetomidine is increased by 0.1mcg/kg/h if OAA/S is greater than 3; The infusion rate is decreased by 0.1mcg/kg/h if OAA/S is less than 3.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

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.

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Iowa Satisfaction with Anesthesia Scale(ISAS)within 30 minutes after the end of surgery (in the PACU)Patient's satisfaction with MAC

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026