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

NCT ID: NCT02283866

Last Updated: 2015-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Administering desflurane according to the patient's BIS value

Intervention Type DRUG

Administering desflurane according to the patient's BIS value

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.

Group Type EXPERIMENTAL

Administering desflurane at 1 MAC

Intervention Type DRUG

Administering desflurane at 1 MAC

Interventions

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Administering desflurane according to the patient's BIS value

Administering desflurane according to the patient's BIS value

Intervention Type DRUG

Administering desflurane at 1 MAC

Administering desflurane at 1 MAC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chul-Woo Jung

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chul-Woo Jung

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33152029 (View on PubMed)

Other Identifiers

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CWJung_BA

Identifier Type: -

Identifier Source: org_study_id

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