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

Validation of Phase Lag Entropy(PLE) as an Indicator of Depth of Sedation in Patients Undergoing Spinal Anesthesia: Comparative Analysis With Bispectral Index

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03319004

Enrollment

Registered

2017-10-24

Start date

2017-07-19

Completion date

2018-07-18

Last updated

2017-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery Requiring Spinal Anesthesia

Brief summary

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.

Interventions

DEVICEapply phase lag entropy sensor

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Inclusion criteria

* patients who require sedation during the spinal anesthesia

Exclusion criteria

* dementia, CVA patients, patients have problems with communication

Design outcomes

Primary

Measure	Time frame	Description
phase lag entropy score	through study completion, an average of 1 year	phase lag entropy score

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026