- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04369014
Effect of Etomidate and Propofol on Electroencephalography (CHAPE)
May 25, 2022 updated by: Zhihong LU, Air Force Military Medical University, China
Characteristic Changes During Anesthesia With Etomidate and Propofol
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhihong Lu
- Phone Number: +862984775343
- Email: deerlu23@163.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Hospital
-
Sub-Investigator:
- Yonghui Wang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: etomidate
|
etomidate is used for induction and maintenance of general anesthesia
|
Experimental: propofol
|
propofol is used for induction and maintenance of general anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
delta wave deficiency during anesthesia
Time Frame: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
|
from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
spindle wave deficiency during anesthesia
Time Frame: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
|
from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
|
burst suppression during anesthesia
Time Frame: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
|
from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2022
Primary Completion (Anticipated)
December 30, 2022
Study Completion (Anticipated)
February 28, 2023
Study Registration Dates
First Submitted
April 27, 2020
First Submitted That Met QC Criteria
April 27, 2020
First Posted (Actual)
April 30, 2020
Study Record Updates
Last Update Posted (Actual)
May 31, 2022
Last Update Submitted That Met QC Criteria
May 25, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJH-A-20200330
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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