Propofol Overdose of Undetermined IntentNCT05158426
Application of the Propofol Precise Infusion Model
An observational study of Propofol Overdose of Undetermined Intent, run by West China Hospital at 1 site in China.
Trial summary
Propofol is one of the most commonly used anesthetics in the world. However, the dose-response of propofol was remarkable variety. Herein, this study aims to investigate the possible association of gene polymorphism and propofol susceptibility, and to research more precise infusion model of this drug. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Propofol Overdose of Undetermined Intent
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2019to 18 Nov 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who will undergo gastrointestinal endoscopy with propofol
Who may be able to join
- patients who undergoing gastrointestinal endoscopy with anesthesia
- age ≥18 years
Who cannot join
- hepatic or kidney function injured;
- received hypnotic sedative drug regularly;
- Pregnancy, excessive drinking, or current smoker;
- be allergic to propofol
- patients who with difficulty communication
Trial locations and contacts
1 site in 1 country.
About this study
Propofol is one of the most commonly used anesthetics in the world. However, the dose-response of propofol was remarkable variety. Herein, this study aims to investigate the possible association of gene polymorphism and propofol susceptibility, and to research more precise infusion model of this drug.
Read the detailed description
Patients undergoing gastrointestinal endoscopy will be recruited. Anesthesia is induced with propofol via TCI at 1.5µg/ml, and increases 0.5µg/ml for every 3min until OAA/S score 0. During this period, OAA/S score will be evaluated every 1min until OAA/S score 0. At this moment, the blood concentration of propofol, the doses of propofol, the onset time and BIS are recorded, and blood sample for gene polymorphism detection were required.
- Conditions
- Propofol Overdose of Undetermined Intent
- Being tested
- Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
anesthesia induction is initiated with intravenous infusion propofol at 1.5µg/ml, and increased 0.5µg/ml every 3min until OAA/S score 0.
| Study group | Role | What they receive |
|---|---|---|
| propofol susceptibility group | patients undergoing gastrointestinal endoscopy Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene polymorphism of propofol susceptibility
combination of the blood concentration of propofol (ng/ml) with the onset time(min) at OAA/S score of 0 to demonstrate propofol susceptibility, the gene polymorphism of propofol susceptibility will be detected with the blood sample of subjects.
Measured: from anesthesia induction to the end of the gastrointestinal endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start20 Nov 2019
- Primary completion15 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol Overdose of Undetermined IntentStudies of the same condition, open and under way.
- More trials run by West China 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Du, West China Hospital
- Investigators
- Weimin Li, Study director, West China Hospitallin Zhang, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158426
- Sponsor's protocol ID
- WestChinaH-2018-1
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Propofol Precise Infusion Model
- ClinicalTrials.gov ID
- NCT05158426
- Acronym / sponsor ID
- WestChinaH-2018-1
- Conditions
- Propofol Overdose of Undetermined Intent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 15 Dec 2021 (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.
Propofol is one of the most commonly used anesthetics in the world. However, the dose-response of propofol was remarkable variety. Herein, this study aims to investigate the possible association of gene polymorphism and propofol susceptibility, and to research more precise infusion model of this drug.
Detailed description
Patients undergoing gastrointestinal endoscopy will be recruited. Anesthesia is induced with propofol via TCI at 1.5µg/ml, and increases 0.5µg/ml for every 3min until OAA/S score 0. During this period, OAA/S score will be evaluated every 1min until OAA/S score 0. At this moment, the blood concentration of propofol, the doses of propofol, the onset time and BIS are recorded, and blood sample for gene polymorphism detection were required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| propofol susceptibility group | – | Drug: Propofolpatients undergoing gastrointestinal endoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who will undergo gastrointestinal endoscopy with propofol
Key inclusion criteria (2 listed)
- patients who undergoing gastrointestinal endoscopy with anesthesia
- age ≥18 years
Key exclusion criteria (5 listed)
- hepatic or kidney function injured;
- received hypnotic sedative drug regularly;
- Pregnancy, excessive drinking, or current smoker;
- be allergic to propofol
- patients who with difficulty communication
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 |
|---|---|---|
| PropofolAlso: Diprivananesthesia induction is initiated with intravenous infusion propofol at 1.5µg/ml, and increased 0.5µg/ml every 3min until OAA/S score 0. | Drug | propofol susceptibility group |
Primary outcome
gene polymorphism of propofol susceptibility
Time frame: from anesthesia induction to the end of the gastrointestinal endoscopy
combination of the blood concentration of propofol (ng/ml) with the onset time(min) at OAA/S score of 0 to demonstrate propofol susceptibility, the gene polymorphism of propofol susceptibility will be detected with the blood sample of subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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.
Weimin Li study director
West China Hospital
lin Zhang study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Propofol Overdose of Undetermined Intent, run by West China Hospital 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 5 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: finished, as of the sponsor's last update on 15 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene polymorphism of propofol susceptibility (time frame: from anesthesia induction to the end of the gastrointestinal endoscopy). 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 15 Dec 2021.