NCT04369014

Brief Summary

Electroencephalography (EEG) monitoring reflect the brain electro-activity. Different anesthetics may show different changes in EEG during anesthesia. Etomidate and propofol are widely used for general anesthesia. The characteristic changes of these two anesthetics may be different.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

April 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

April 27, 2020

Last Update Submit

May 25, 2022

Conditions

General Anesthesia

Keywords

electroencephalographyetomidatepropofol

Outcome Measures

Primary Outcomes (1)

  • delta wave deficiency during anesthesia

    from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours

Secondary Outcomes (2)

  • spindle wave deficiency during anesthesia

    from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours

  • burst suppression during anesthesia

    from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours

Study Arms (2)

etomidate

EXPERIMENTAL
Drug: etomidate anesthesia

propofol

EXPERIMENTAL
Drug: propofol anesthesia

Interventions

etomidate anesthesiaDRUG

etomidate is used for induction and maintenance of general anesthesia

etomidate
propofol anesthesiaDRUG

propofol is used for induction and maintenance of general anesthesia

propofol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for surgery under general anesthesia
  • Patients provided written informed consent

You may not qualify if:

  • Patients with history of neurological or psychiatric diseases
  • Patients younger than 18 years old
  • Patients scheduled for surgery involved head
  • Patients with pregnancy or planned for breeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Central Study Contacts

Zhihong Lu

CONTACT

+862984775343deerlu23@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 30, 2020

Study Start

February 28, 2022

Primary Completion

December 30, 2022

Study Completion

February 28, 2023

Last Updated

May 31, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)