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

NCT ID: NCT05208502

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-22

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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General Anesthetic Drug Adverse Reaction Perioperative/Postoperative Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

DSA monitor

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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the time when the inclusion started emergence to extubation will be recorded

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Feng-Fang Tsai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Operation Theater, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Feng-Fang Tsai

Role: CONTACT

886-2-3123456 ext. 62158

Facility Contacts

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Feng-Fang Tsai

Role: primary

0972653390

Other Identifiers

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201912250RINC

Identifier Type: -

Identifier Source: org_study_id

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