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

Perioperative/Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208502
• Other study ID #: 201912250RINC
• Status: Recruiting
• Start date: February 22, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: National Taiwan University Hospital
• Contact: Feng-Fang Tsai
• Phone: 886-2-3123456
• Email: 010388[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• General Anesthetic Drug Adverse Reaction
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Device:
• DSA monitor
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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DSA monitor group has less emergence time	Patients with SedLine monitor may have shorter emergence time. The prolonged emergence rate is low with SedLine monitor.	24 hours