General AnesthesiaCHAPENCT04369014
Effect of Etomidate and Propofol on Electroencephalography
A study testing etomidate anesthesia and propofol anesthesia in people with General Anesthesia, run by Air Force Military Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- etomidate anesthesia and propofol anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for surgery under general anesthesia
- Patients provided written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710032
Zhihong Lu, +8613891975018, deerlu23@163.com
Yonghui Wang
About this study
Official title: 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.
- Conditions
- General Anesthesia
- Being tested
- etomidate anesthesia, propofol anesthesia
- Keywords
- electroencephalography, etomidate, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etomidate anesthesiaDrug
etomidate is used for induction and maintenance of general anesthesia
propofol anesthesiaDrug
propofol is used for induction and maintenance of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| etomidate | Experimental | Not described Receives: Drug: etomidate anesthesia |
| propofol | Experimental | Not described Receives: Drug: propofol anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
delta wave deficiency during anesthesia
Measured: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
Secondary outcomes (2)
spindle wave deficiency during anesthesia
Measured: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
burst suppression during anesthesia
Measured: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start28 Feb 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369014
- Sponsor's protocol ID
- XJH-A-20200330
- Acronym
- CHAPE
- Status last verified
- May 2022
- First submitted
- 27 Apr 2020
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristic Changes During Anesthesia With Etomidate and Propofol
- ClinicalTrials.gov ID
- NCT04369014
- Acronym / sponsor ID
- CHAPE / XJH-A-20200330
- Conditions
- General Anesthesia
- Keywords
- electroencephalography, etomidate, propofol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etomidate | Experimental | Drug: etomidate anesthesia |
| propofol | Experimental | Drug: propofol anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for surgery under general anesthesia
- Patients provided written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etomidate anesthesiaetomidate is used for induction and maintenance of general anesthesia | Drug | etomidate |
| propofol anesthesiapropofol is used for induction and maintenance of general anesthesia | Drug | propofol |
Primary outcome
delta wave deficiency during anesthesia
Time frame: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours
2 secondary outcomes
spindle wave deficiency during anesthesia
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing etomidate anesthesia and propofol anesthesia in people with General Anesthesia, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Lu (+862984775343, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delta wave deficiency during anesthesia (time frame: from anesthesia induction to extubation of the endotracheal tube, on an average of 2.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.