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Validation of Phase Lag Entropy(PLE) as an Indicator of Depth of Sedation in Patients Undergoing Spinal Anesthesia

NCT ID: NCT03319004

Last Updated: 2017-10-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2018-07-18

Brief Summary

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For verifying the phase lag entropy as the tool for measurement of level of consciousness, the investigators compared phase lag entropy to bispectral index. Using Target-Controlled Infusion pump, propofol was infused for sedation during the spinal anesthesia. The investigators measured Observer's Assessment of Alertness/Sedation Scale as the propofol concentration rises. At the same time, The investigators observed phase lag entropy score and bispectral index score.

Detailed Description

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Conditions

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Surgery Requiring Spinal Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Compare bispectral index and phase lag entropy

Group Type EXPERIMENTAL

apply phase lag entropy sensor

Intervention Type DEVICE

apply phase lag entropy sensor as well as bispectral index sensor on forehead during the sedation using propofol

Interventions

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apply phase lag entropy sensor

apply phase lag entropy sensor as well as bispectral index sensor on forehead during the sedation using propofol

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients who require sedation during the spinal anesthesia

Exclusion Criteria

* dementia, CVA patients, patients have problems with communication
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Woo Han

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2017-0145

Identifier Type: -

Identifier Source: org_study_id