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Clinical Trials/NCT05208502
NCT05208502
Recruiting
Not Applicable

Observation of Emergence Time Between Patients Receive General Anesthesia With BIS or 4-channel Spectrogram EEG Monitor

National Taiwan University Hospital1 site in 1 country126 target enrollmentFebruary 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Anesthetic Drug Adverse Reaction
Sponsor
National Taiwan University Hospital
Enrollment
126
Locations
1
Primary Endpoint
DSA monitor group has less emergence time
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The bispectral index parameter is used to guide the titration of general anesthesia, however; conflicting results between different studies cannot prove the benefit of EEG monitor on improvement of OR efficiency. Next Generation SedLine features an enhanced signal processing engine, which provides processed EEG parameters. This four channel EEG monitor for the monitoring of perioperative anesthesia depth prevent overdose of medication and may help for individualized anesthetic plan. This research intended to observe the emergence time from end of the surgical wound closure to patient awake (or to extubation) with or without SedLine.

Detailed Description

This is a clinical observation study. Inclusion criteria are patients with ASA 1-3, age over 20 who need general anesthesia surgery without other neurologic disease. All inclusions will receive the general anesthesia with SedLine monitor, a researcher who is not participated in the clinical practice will record the emergence characters and the EEG monitor signal. The Controls were patients with same criteria without BIS monitor. Sample size was decided if the estimated difference between SedLine group and BIS group are 1 minute and the average estimated as 2 minute. With 80% desired power and default is .05, each group will need 63 cases.

Registry
clinicaltrials.gov
Start Date
February 22, 2022
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients who need routine general anesthesia
  • have no neurological problem
  • have no dermo issue over forehead area
  • not allergic to the patch

Exclusion Criteria

  • patients who is not agreed

Outcomes

Primary Outcomes

DSA monitor group has less emergence time

Time Frame: 24 hours

Patients with SedLine monitor may have shorter emergence time. The prolonged emergence rate is low with SedLine monitor.

Study Sites (1)

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