Comparison of Effect of Equi-MAC Anesthetics on PSI

NCT ID: NCT03587779

Last Updated: 2020-09-03

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

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-24

Study Completion Date

2019-01-22

Brief Summary

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The aim of this study is to compare the patient state index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent volatile anesthesia.

Detailed Description

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There have been several studies comparing electroencephalogram-derived indices produced by sevoflurane and desflurane. However, to the best of our knowledge, there has been no study which compared the two inhaled anesthetics using patient state index. Therefore, the aim of this study is to compare the patient state index values produced by sevoflurane and desflurane at equi-MAC in patients undergoing single-agent inhalation anesthesia.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sevoflurane

Anesthesia is maintained with sevoflurane.

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Throughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration.

Desflurane

Anesthesia is maintained with desflurane.

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

Throughout the study period, anesthesia is maintained with desflurane of age-corrected equivalent minimum alveolar concentration.

Interventions

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Sevoflurane

Throughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration.

Intervention Type DRUG

Desflurane

Throughout the study period, anesthesia is maintained with desflurane of age-corrected equivalent minimum alveolar concentration.

Intervention Type DRUG

Other Intervention Names

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Sevorane Suprane

Eligibility Criteria

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Inclusion Criteria

* patients aged between 19 and 65 yr
* patients with American Society of Anesthesiologists physical status classification I or II
* patients scheduled for elective surgery under volatile anesthesia
* patients obtaining written informed consent

Exclusion Criteria

* patients with a history of any psychiatric or neurological disease
* patients receiving any medication affecting the autonomic or central nervous system
* patients with a history of alcohol or drug abuse
* pregnant or lactating women
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyoung-Ho Ryu, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyoung-Ho Ryu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

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Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2018-05-045

Identifier Type: -

Identifier Source: org_study_id

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