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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03410082

Collaborator

(none)

Enrollment

Location

Arms

19.4

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bispectral Index, Monitored Anesthesia Care	Device: Titration under the guidance of BIS Diagnostic Test: Titration under the guidance of OAA/S	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

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.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 15, 2017

Actual Primary Completion Date :

Mar 30, 2019

Actual Study Completion Date :

Mar 30, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul	Agree	Korea, Republic of	110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ho Geol Ryu, Assistant professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT03410082

Other Study ID Numbers:

snuhksm

First Posted:

Jan 25, 2018

Last Update Posted:

Sep 25, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 25, 2019