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

Yonsei University Health System (YUHS)

Status: Unknown

Conditions: Surgery Requiring Spinal Anesthesia

Treatments: Device: apply phase lag entropy sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT03319004

3-2017-0145

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who require sedation during the spinal anesthesia

Exclusion criteria

• dementia, CVA patients, patients have problems with communication

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Compare bispectral index and phase lag entropy

Experimental group

Treatment:

Device: apply phase lag entropy sensor