NCT04431557

Brief Summary

The investigators will record 120 patients who received general anesthesia, their EEG data recorded from Bispectral Index (BIS) machine for emperical mode decomposition (EMD) analysis, the investigators decomposed EEG signal to different oscillations and tried to observe the differences between hypnotic medications through EEG analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
Last Updated

June 16, 2020

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

June 9, 2020

Last Update Submit

June 11, 2020

Conditions

SevofluranePropofol

Outcome Measures

Primary Outcomes (1)

  • The gamma, beta, alpha and theta power of EEG

    We will try to observe the differences between hypnotic medications through EEG decomposed and power analysis.

    the total duration inclusions in operation room

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population was focus on the patients who need schedule general anesthesia with low anesthesia risk (ASA I-II).

You may qualify if:

  • ASA I-II
  • scheduled surgery who need general anesthesia

You may not qualify if:

  • allergy to the BIS patch
  • not suitable for general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Study Officials

  • Feng-Fang Tsai, M.D.

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 16, 2020

Study Start

July 19, 2017

Primary Completion

February 19, 2019

Study Completion

February 19, 2019

Last Updated

June 16, 2020

Record last verified: 2017-07

Locations

TW(1)