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Observational of Emergence Time Between Patients Receive General Anesthesia With BIS or Spectrogram EEG Monitor

Recruiting
Conditions
General Anesthetic Drug Adverse Reaction
Perioperative/Postoperative Complications
Interventions
Device: DSA monitor
Registration Number
NCT05208502
Lead Sponsor
National Taiwan University Hospital
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
126
Inclusion Criteria
  • patients who need routine general anesthesia
  • have no neurological problem
  • have no dermo issue over forehead area
  • not allergic to the patch
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Exclusion Criteria
  • patients who is not agreed
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
DSADSA monitorAll 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 DSA monitor signal. As the surgery ends, this researcher will record the time started from the end of the surgery to extubation, as well as the emergence quality when the patient was evaluated.
Primary Outcome Measures
NameTimeMethod
DSA monitor group has less emergence time24 hours

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

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