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

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Seoul National University

Status

Terminated

Conditions

Bispectral Index, Monitored Anesthesia Care

Treatments

Device: Titration under the guidance of BIS
Diagnostic Test: Titration under the guidance of OAA/S

Study type

Interventional

Funder types

Other

Identifiers

NCT03410082
snuhksm

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

31 participants in 2 patient groups

OAA/S
Active Comparator group
Description:
The patients in the control group will receive MAC titrated according to observer's assessment of anesthesia/sedation(OAA/S) score.
Treatment:
Diagnostic Test: Titration under the guidance of OAA/S
BIS
Active Comparator group
Description:
The patients in the control group will receive MAC titrated according to bispectral index(BIS).
Treatment:
Device: Titration under the guidance of BIS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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