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

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

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 Overview

• Status: Terminated
• Conditions: Bispectral Index, Monitored Anesthesia Care
• Intervention / Treatment: Diagnostic test: Titration under the guidance of OAA/S; Device: Titration under the guidance of BIS

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Agree
    • Seoul, Agree, Korea, Republic of, 110-744
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OAA/S; The patients in the control group will receive MAC titrated according to observer's assessment of anesthesia/sedation(OAA/S) score.	Diagnostic test: Titration 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.
Active Comparator: BIS; The patients in the control group will receive MAC titrated according to bispectral index(BIS).	Device: Titration 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iowa Satisfaction with Anesthesia Scale(ISAS)	Patient's satisfaction with MAC	within 30 minutes after the end of surgery (in the PACU)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: snuhksm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No