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

NCT ID: NCT03410082

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2019-03-30

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.

Conditions

Bispectral Index, Monitored Anesthesia Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

OAA/S

The patients in the control group will receive MAC titrated according to observer's assessment of anesthesia/sedation(OAA/S) score.

Group Type: ACTIVE_COMPARATOR

Titration under the guidance of OAA/S

Intervention Type: DIAGNOSTIC_TEST

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.

BIS

The patients in the control group will receive MAC titrated according to bispectral index(BIS).

Group Type: ACTIVE_COMPARATOR

Titration under the guidance of BIS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ho Geol Ryu

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, Agree, South Korea

Countries

South Korea

Other Identifiers

snuhksm

Identifier Type: -

Identifier Source: org_study_id