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

Not Applicable

Completed

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

• Registration Number: NCT02283866
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-13
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Administering desflurane according to the patient's BIS value	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.
Administering desflurane at 1 MAC	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.

Primary Outcome Measures

Name	Time	Method
The difference of 'wobble' value of the patients' BIS value between the two groups	Every second from 10 minutes after skin incision to 10 minutes before surgery end.	'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}

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of