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

NCT05208502 | Unknown

• 1 other identifier: 201912250RINC
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthetic Drug Adverse Reaction; Perioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

DSA monitor DEVICE

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

Also known as: the time when the inclusion started emergence to extubation will be recorded

DSA

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who need routine general anesthesia

You may qualify if:

• patients who need routine general anesthesia
• have no neurological problem
• have no dermo issue over forehead area
• not allergic to the patch

You may not qualify if:

• patients who is not agreed

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Feng-Fang Tsai, MD, PhD

  Operation Theater, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng-Fang Tsai

CONTACT

886-2-3123456; 010388@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: January 26, 2022
• Study Start: February 22, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 24, 2024

Record last verified: 2023-02

Locations

TW (1)