FentanylNCT03869346
Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients
An observational study of Fentanyl, run by Peking University People's Hospital at 1 site in China.
Trial summary
Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on non-analgesic effects of fentanyl in Chinese Han patients. Methods: 200 patients receiving elective surgery under general anesthesia were recruited into this study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fentanyl
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2019to 20 May 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 200 Chinese Han patients receiving elective surgery under general anesthesia
Who may be able to join
- American Society of Anesthesiologists GradeⅠ-II,Patients undergo elective surgery for benign Reproductive diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, laparoscopic salpingoplasty, etc.) or breast disease.
- Aged 18-45 years
- Body Mass Index 18-25kg/m2,body weight 40-65 kilograms
- Agreed to participate the research
Who cannot join
- Difficult airway
- upper respiratory tract infection within 2 weeks
- history of allergy or long-term use of propofol and opioids
- self-rating anxiety scale before operation indicates anxiety
- pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
qi yan, 8613811319638, yanqi04@163.com
About this study
Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on non-analgesic effects of fentanyl in Chinese Han patients. Methods: 200 patients receiving elective surgery under general anesthesia were recruited into this study. Venous blood was withdrawn for genotyping of CYP3A4*1G before operation. Fentanyl 2 µg/kg was administered preoperatively. Bispectral Index (BIS), Respiratory rate(RR), etc at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.
- Conditions
- Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GG | wild-type homozygote (CYP3A4*1/*1, GG) | |
| GA | mutant heterozygote (CYP3A4*1/*1G, GA), | |
| AA | mutant homozygote (CYP3A4*1G/*1G, AA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
bispectral index
bispectral index(BIS): assessing the sedation, placed on the patient's forehead, BIS values 0-100, and the higher score means patients are more conscious
Measured: 20 min after administration
respiratory rate
Number of breaths per minute
Measured: 20 min after administration
CYP3A4*1G Polymorphism
The patients were classified by genotype including wild-type homozygote (CYP3A4*1/*1, GG), mutant heterozygote (CYP3A4*1/*1G, GA), and mutant homozygote (CYP3A4*1G/*1G, AA).
Measured: 1 week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start10 Mar 2019
- Primary completion10 Mar 2021 (estimated)
- Study completion20 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FentanylStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Responsible party
- Principal investigator, Yanqi, Peking University People's Hospital
- Investigators
- Yi Feng, Professor, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869346
- Sponsor's protocol ID
- NAOOP
- Status last verified
- Sep 2019
- First submitted
- 1 Mar 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients
- ClinicalTrials.gov ID
- NCT03869346
- Acronym / sponsor ID
- NAOOP
- Conditions
- Fentanyl
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 20 May 2021 (estimated)
- First posted
- 11 Mar 2019 (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.
Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on non-analgesic effects of fentanyl in Chinese Han patients. Methods: 200 patients receiving elective surgery under general anesthesia were recruited into this study. Venous blood was withdrawn for genotyping of CYP3A4*1G before operation. Fentanyl 2 µg/kg was administered preoperatively. Bispectral Index (BIS), Respiratory rate(RR), etc at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GG | – | –wild-type homozygote (CYP3A4*1/*1, GG) |
| GA | – | –mutant heterozygote (CYP3A4*1/*1G, GA), |
| AA | – | –mutant homozygote (CYP3A4*1G/*1G, AA) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 200 Chinese Han patients receiving elective surgery under general anesthesia
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists GradeⅠ-II,Patients undergo elective surgery for benign Reproductive diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, laparoscopic salpingoplasty, etc.) or breast disease.
- Aged 18-45 years
- Body Mass Index 18-25kg/m2,body weight 40-65 kilograms
- Agreed to participate the research
Key exclusion criteria (5 listed)
- Difficult airway
- upper respiratory tract infection within 2 weeks
- history of allergy or long-term use of propofol and opioids
- self-rating anxiety scale before operation indicates anxiety
- pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
bispectral index
Time frame: 20 min after administration
bispectral index(BIS): assessing the sedation, placed on the patient's forehead, BIS values 0-100, and the higher score means patients are more conscious
respiratory rate
Time frame: 20 min after administration
Number of breaths per minute
CYP3A4*1G Polymorphism
Time frame: 1 week after operation
The patients were classified by genotype including wild-type homozygote (CYP3A4*1/*1, GG), mutant heterozygote (CYP3A4*1/*1G, GA), and mutant homozygote (CYP3A4*1G/*1G, AA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- 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.
Yi Feng, Professor study director
Peking University People's 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 Fentanyl, run by Peking University People's 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 4 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: status not confirmed, as of the sponsor's last update on 6 Sep 2019. 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 Qi Yan, MD (13811319638, yanqi04@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bispectral index (time frame: 20 min after administration). The study lists 3 primary outcomes in all. 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 6 Sep 2019.