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

Surgery Requiring Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03319004
• Other study ID #: 3-2017-0145
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 1, 2017
• Last updated: October 22, 2017
• Start date: July 19, 2017
• Est. completion date: July 18, 2018

Study information

• Verified date: October 2017
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 27
• Est. completion date: July 18, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• patients who require sedation during the spinal anesthesia

Exclusion Criteria:

• dementia, CVA patients, patients have problems with communication

Related Conditions & MeSH terms

• Surgery Requiring Spinal Anesthesia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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