Bispectral Index-Guided Versus Fixed Dose Administration of Desflurane During Balanced Anesthesia With Remifentanil

Balanced anesthesia combining volatile anesthetics and opioids is commonly used in modern anesthesia. The purpose of this study is to compare two methods of administering desflurane, an volatile anesthetic during balanced anesthesia. The investigators hypothesized that administering desflurane at 1 MAC (minimum alveolar concentration) during balanced anesthesia will be more beneficial in terms of stability of the patient's vital signs and hypnotic depth than administering desflurane according to the patient's BIS (bispectral index) value.

Study Overview

• Status: Completed
• Conditions: Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia
• Intervention / Treatment: Drug: Administering desflurane according to the patient's BIS value; Drug: Administering desflurane at 1 MAC

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for operation under balanced anesthesia using desflurane and remifentanil

Exclusion Criteria:

• Refusal of consent
• General anesthesia with agents other than desflurane and remifentanil
• Patients with allergy to neuromuscular blocker, volatile anesthetics, opioids
• History of malignant hyperthermia
• Patients taking CNS stimulants
• Chronic alcohol abuser
• Patients with severe depressed left ventricular function, EF < 30%
• Patients with convulsive disorders
• ASA class IV, V, VI
• Patients with systolic arterial blood pressure lower than 90mmHg before surgery
• Patients needing inotropic infusion during surgery
• Anesthesia time less than 30 minutes

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administering desflurane according to the patient's BIS value; The anesthesiologist administers the volatile anesthetic desflurane to set the patient's BIS value at 50 during balanced anesthesia, and titrate the remifentanil dose to set the patient's systolic arterial blood pressure between 100-140mmHg.	Drug: Administering desflurane according to the patient's BIS value; Administering desflurane according to the patient's BIS value
Experimental: Administering desflurane at 1 MAC; The anesthesiologist administers the volatile anesthetic desflurane at 1 MAC during balanced anesthesia, and titrate the remifentanil dose to set the patient's systolic arterial blood pressure between 100-140mmHg.	Drug: Administering desflurane at 1 MAC; Administering desflurane at 1 MAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of 'wobble' value of the patients' BIS value between the two groups	'Wobble' is a variable that can measure the performance measurement of a pharmacokinetic model, or the reaction of the patient to a drug. We can calculate the performance error from the target of the therapy and the actual measured value, and derive the wobble by a specific formulas, which are described below. PE=(BISmeasured-BIStargeted)x100/BIStargeted MDPEi = median{PEij, j=1,…,Ni} MDAPEi = median{|PEij|, j=1,…,Ni} Wobblei = median{|PEij-MDPEi|, j=1,…,Ni} Divergence = slope{|PEij|, j=1,…,Ni}	Every second from 10 minutes after skin incision to 10 minutes before surgery end.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of 'wobble' value of the patients' systolic arterial blood pressure value between the two groups	Described above	Every 2.5 minutes from 10 minutes after skin incision to 10 minutes before surgery end

Other Outcome Measures

Outcome Measure	Time Frame
Eye opening time to prodding after stopping of anesthetics.	1 min,2 min,3 min, 4min, 5min, 6min, 7min, 8min, 9min, 10min after stopping injection of anesthetics

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chul-Woo Jung, Seoul National University Hospital

Publications and helpful links

General Publications

• Yang SM, Jung YS, Jung CW, Kim WH, Yoon SB, Lee HC. Comparison of bispectral index-guided and fixed-gas concentration techniques in desflurane and remifentanil anesthesia: A randomized controlled trial. PLoS One. 2020 Nov 5;15(11):e0241828. doi: 10.1371/journal.pone.0241828. eCollection 2020.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 5, 2014

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Desflurane
• Other Study ID Numbers: CWJung_BA