NCT03303443

Brief Summary

Bispectral index (BIS), a standard monitor for perioperative monitor of patient's conscious level, is a noninvasive medical technique for monitoring and recording the electrical activity of brain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

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

First Submitted

Initial submission to the registry

December 1, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

May 15, 2016

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

June 5, 2020

Status Verified

April 1, 2019

Enrollment Period

3.1 years

First QC Date

December 1, 2015

Last Update Submit

June 4, 2020

Conditions

Depth of Anesthesia

Outcome Measures

Primary Outcomes (1)

  • EEG power calculation

    The investigator use root mean square energy to calculate EEG power.

    During the operation time.

Study Arms (2)

Younger

20-40 years old patients

Elderly

over 60 years old patients

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

20-40y/o patients or over 60y/o patients without severe systemic disease who were scheduled for general anesthesia.

You may qualify if:

  • y/o or over 60y/o
  • Scheduled for low risk general anesthesia
  • Suitable for surgery after interviewed by anesthesiologist

You may not qualify if:

  • Not suitable for general anesthesia
  • High risk patient
  • Allergic to the EEG sensor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feng-Fang Tsai

Taipei, 100, Taiwan

Location

Study Officials

  • Feng-Fang Tsai, MD

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 1, 2015

First Posted

October 6, 2017

Study Start

May 15, 2016

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

June 5, 2020

Record last verified: 2019-04

Locations

TW(1)