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

Not Applicable

• Conditions: Surgery Requiring Spinal Anesthesia
• Interventions: Device: apply phase lag entropy sensor

• Registration Number: NCT03319004
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-19
• Status Verified: 2017-10
• Study First Submitted: 2017-10-01
• Study First Submitted QC: 2017-10-22
• Last Update Submitted: 2017-10-22
• Study First Posted: 2017-10-24
• Last Update Posted: 2017-10-24
• Primary Completion: 2018-01-31
• Study Completion: 2018-07-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• patients who require sedation during the spinal anesthesia

Exclusion Criteria

• dementia, CVA patients, patients have problems with communication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Compare bispectral index and phase lag entropy	apply phase lag entropy sensor	-

Primary Outcome Measures

Name	Time	Method
phase lag entropy score	through study completion, an average of 1 year	phase lag entropy score

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of