Effect of Etomidate and Propofol on Electroencephalography | NCT04369014

Studies
Effect of Etomidate and Propofol on Electroencephalography

NCT04369014

Sponsor

Air Force Military Medical University, China

Status

Unknown status

Last Update Posted

May 31, 2022Actual

Enrollment

68Estimated

Phase

Not Applicable

Conditions

General Anesthesia

Interventions

etomidate anesthesia
propofol anesthesia

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2022Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Feb 28, 2023Estimated

First Submitted Date

Apr 27, 2020

First Submission Date that Met QC Criteria

Apr 27, 2020

First Posted Date

Apr 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2022

Last Update Posted Date

May 31, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhihong LU, Professor, Air Force Military Medical University, ChinaPrincipal Investigator

Lead Sponsor

Air Force Military Medical University, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
etomidate	Experimental		Drug: etomidate anesthesia
propofol	Experimental		Drug: propofol anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
etomidate anesthesia	Drug	etomidate is used for induction and maintenance of general anesthesia	etomidate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
delta wave deficiency during anesthesia		from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhihong Lu	Contact	+862984775343		deerlu23@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijing hospital	Recruiting	Xi'an	Shaanxi	710032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided