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

Bispectral Index, Monitored Anesthesia Care Clinical Trial

— BISMAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03410082
• Other study ID #: snuhksm
• Status: Terminated
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bispectral Index, Monitored Anesthesia Care

Intervention

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.

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Agree

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iowa Satisfaction with Anesthesia Scale(ISAS)	Patient's satisfaction with MAC	within 30 minutes after the end of surgery (in the PACU)