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

Last updated: January 23, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

DSA monitor

Clinical Study ID

NCT05208502
201912250RINC
  • Ages 20-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • patients who is not agreed

Study Design

Total Participants: 126
Treatment Group(s): 1
Primary Treatment: DSA monitor
Phase:
Study Start date:
February 22, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • National Taiwan University Hospital

    Taipei, 100225
    Taiwan

    Active - Recruiting

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