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

National Taiwan University

Status: Enrolling

Conditions: Perioperative/Postoperative Complications; General Anesthetic Drug Adverse Reaction

Treatments: Device: DSA monitor

Study type: Observational

Funder types: Other

Identifiers

NCT05208502

201912250RINC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

126 participants in 2 patient groups

BIS

Description:

All inclusions will receive the general anesthesia with BIS monitor, a researcher who is not participated in the clinical practice will record the emergence characters and the EEG 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.

DSA

Description:

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 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.

Treatment:

Device: DSA monitor