PropofolNCT03762538
The Effect of the ALDH2 Gene Polymorphism on the Propofol Potency for Inducing Loss of Consciousness
An observational study of Propofol, run by Shanghai Zhongshan Hospital.
Trial summary
The aim of this study is to determine whether ALDH2 gene polymorphisms (G/G, G/A A/A) have effect on the potency of propofol. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Propofol
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 31 Dec 2019
- Phase
- Observational
- 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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: operation rooms for cardiac surgeries in our institution（a major hospital in China)
Who may be able to join
- ASA II
Who cannot join
- ASA III-IV
- OSAS
- hepatic and renal insufficiency
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of the ALDH2 Gene Polymorphism on the Propofol Potency for Inducing Loss of Consciousness in Cardiac Patients: a Prospective Observational Study
The aim of this study is to determine whether ALDH2 gene polymorphisms (G/G, G/A A/A) have effect on the potency of propofol.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Patients will be induced to unconsciousness using propofol intravenously.
| Study group | Role | What they receive |
|---|---|---|
| G/G group | Patients who are determined to be G/G genotype. Receives: Drug: Propofol | |
| G/A A/A group | Patients who are determined to be G/A or A/A genotypes. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect-site concentration
patient's effect-site concentration when he/she loss consciousness
Measured: immediately after patient lose his/her consciousness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Feb 2019 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PropofolStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762538
- Sponsor's protocol ID
- EAGLES
- Status last verified
- Jan 2018
- First submitted
- 27 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the ALDH2 Gene Polymorphism on the Propofol Potency for Inducing Loss of Consciousness in Cardiac Patients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03762538
- Acronym / sponsor ID
- EAGLES
- Conditions
- Propofol
- Keywords
- propofol, ALDH2, potency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 3 Dec 2018 (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.
The aim of this study is to determine whether ALDH2 gene polymorphisms (G/G, G/A A/A) have effect on the potency of propofol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G/G group | – | Drug: PropofolPatients who are determined to be G/G genotype. |
| G/A A/A group | – | Drug: PropofolPatients who are determined to be G/A or A/A genotypes. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- operation rooms for cardiac surgeries in our institution（a major hospital in China)
Key inclusion criteria (1 listed)
- ASA II
Key exclusion criteria (3 listed)
- ASA III-IV
- OSAS
- hepatic and renal insufficiency
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 |
|---|---|---|
| PropofolPatients will be induced to unconsciousness using propofol intravenously. | Drug | G/A A/A group, G/G group |
Primary outcome
Effect-site concentration
Time frame: immediately after patient lose his/her consciousness
patient's effect-site concentration when he/she loss consciousness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Propofol, run by Shanghai Zhongshan Hospital.
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 1 inclusion and 3 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 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Kefang Guo, MD (+86-13817706936, drguokefang@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect-site concentration (time frame: immediately after patient lose his/her consciousness). 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 3 Dec 2018.