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

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

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.

Study Overview

• Status: Recruiting
• Conditions: General Anesthetic Drug Adverse Reaction; Perioperative/Postoperative Complications
• Intervention / Treatment: Device: DSA monitor

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.

• Study Type: Observational
• Enrollment (Estimated): 126

Contacts and Locations

• Study Contact: Name: Feng-Fang Tsai; Phone Number: 62158 886-2-3123456; Email: 010388@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100225
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Feng-Fang Tsai; Phone Number: 0972653390; Email: 010388@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients who need routine general anesthesia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BIS; 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; 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.	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; Other Names: the time when the inclusion started emergence to extubation will be recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Feng-Fang Tsai, MD, PhD, Operation Theater, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Postoperative Complications; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 201912250RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No