General AnesthesiaNCT03422315
Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection
A study testing Propofol in people with General Anesthesia, run by Zhongyuan Xu at 1 site in China.
Trial summary
Propofol is a widely used sedative anesthetic, but there are large individual differences, which making different patients with different sensitivity to propofol. The aim of this study was to analyze the effects of age, height, body weight, Drinking, metabolic enzymes CYP2B6 and UGT1A9 on Pharmacological effects and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2018to Sep 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients aged 18-60 years (including those aged 18 and 60) who underwent gastrointestinal endoscopy;
- weight should not be less than (≥) 50kg, not more than (≤) 80kg. Body mass index (BMI) = body weight kg / [(height m) 2], in the normal range of 19 to 25;
- American Society of Anesthesiologists (ASA) grading (Appendix I): I or II;
- no heart, liver, lung, kidney, digestive tract, nervous system, mental disorders and other medical history, no blood and metabolic diseases and other medical history, no potential difficulties airway and special past history,
- blood, urine, stool routine, liver and kidney function, blood lipids, ECG, chest X-ray and blood pressure normal, or abnormal but no clinical significance, the researchers believe that can be grouped.
- agree and sign informed consent.
Who cannot join
- important organs have primary disease;
- persons with mental or physical disabilities;
- those suffering from neurological or mental illness, a history of epilepsy;
- patients with cardiovascular or respiratory insufficiency and hypovolemia;
- obese or those with dyslipidemia;
- hereditary acute porphyria;
Show all 14Show fewer
- infections, especially those with respiratory and central infections;
- language exchange barriers;
- suspected or indeed a history of alcohol, drug abuse; especially long-term use of non-steroidal anti-inflammatory drugs, opioids, tranquilizers;
- allergies, if the history of drugs or food allergies; or known to propofol, soybeans, peanuts, coconut oil allergy;
- smoking history (smoking ≥ 5 per day);
- 2 weeks before the trial had used all kinds of Chinese and Western medicine;
- the last 3 months of blood donors and test blood donors;
- other circumstances that the researcher thinks can not be grouped (eg, frail, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital，Southern Medical University
Guangzhou, Guangdong, 510515
zhongyuan xu, Ph.D, nfgcp@126.com
wanwen cao, master, nfyyqc@126.com
About this study
Official title: Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection in Adult Patients With General Anesthesia
Propofol is a widely used sedative anesthetic, but there are large individual differences, which making different patients with different sensitivity to propofol. The aim of this study was to analyze the effects of age, height, body weight, Drinking, metabolic enzymes CYP2B6 and UGT1A9 on Pharmacological effects and pharmacokinetics of propofol, and to provide a reasonable reference for clinical anesthesia patients and evidence for individual dosage regimens.
Read the detailed description
Propofol is a widely used sedative anesthetic, but there are large individual differences, which making different patients with different sensitivity to propofol. In recent years, the concept of individualized administration came into being.Individual administration refers to according to the condition of patients,the drug's safety and efficacy, and pharmacokinetics, pharmacodynamics and clinical response ,then gives different dosing regimens for individual patients and promotes the development of rational drug use. Different people have differences metabolism of propofol, reported in the literature, genetic polymorphism, demographic characteristics, combined with drug and other variability factors, all of them will affect the pharmacokinetics and pharmacodynamics of propofol.The aim of this study was to analyze the effects of age, height, body weight, Drinking, metabolic enzymes CYP2B6 and UGT1A9 on Pharmacological effects and pharmacokinetics of propofol, and to provide a reasonable reference for clinical anesthesia patients and evidence for individual dosage regimens.
- Conditions
- General Anesthesia
- Being tested
- Propofol
- Keywords
- Propofol, Population pharmacokinetics, Individualized administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
injection;2mg/kg;single-dose
| Study group | Role | What they receive |
|---|---|---|
| External control | Experimental | propofol;injection;2mg/kg;single-dose Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS
bispectral index monitoring
Measured: 210min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start3 Sep 2018
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongyuan Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhongyuan Xu, Nanfang Hospital, Southern Medical University
- Investigators
- zhongyuan xu, Ph.D., Study director, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422315
- Sponsor's protocol ID
- C1033453
- Status last verified
- Mar 2021
- First submitted
- 8 Jun 2017
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kansaku F, Kumai T, Sasaki K, Yokozuka M, Shimizu M, Tateda T, Murayama N, Kobayashi S, Yamazaki H. Individual differences in pharmacokinetics and pharmacodynamics of anesthetic agent propofol with regard to CYP2B6 and UGT1A9 genotype and patient age. Drug Metab Pharmacokinet. 2011;26(5):532-7. doi: 10.2133/dmpk.dmpk-11-rg-039. Epub 2011 Aug 23.
PubMed 21869535Bernard O, Guillemette C. The main role of UGT1A9 in the hepatic metabolism of mycophenolic acid and the effects of naturally occurring variants. Drug Metab Dispos. 2004 Aug;32(8):775-8. doi: 10.1124/dmd.32.8.775.
PubMed 15258099Takahashi H, Maruo Y, Mori A, Iwai M, Sato H, Takeuchi Y. Effect of D256N and Y483D on propofol glucuronidation by human uridine 5'-diphosphate glucuronosyltransferase (UGT1A9). Basic Clin Pharmacol Toxicol. 2008 Aug;103(2):131-6. doi: 10.1111/j.1742-7843.2008.00247.x.
PubMed 18816295Khan MS, Zetterlund EL, Green H, Oscarsson A, Zackrisson AL, Svanborg E, Lindholm ML, Persson H, Eintrei C. Pharmacogenetics, plasma concentrations, clinical signs and EEG during propofol treatment. Basic Clin Pharmacol Toxicol. 2014 Dec;115(6):565-70. doi: 10.1111/bcpt.12277. Epub 2014 Jul 19.
PubMed 24891132
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection in Adult Patients With General Anesthesia
- ClinicalTrials.gov ID
- NCT03422315
- Acronym / sponsor ID
- C1033453
- Conditions
- General Anesthesia
- Keywords
- Propofol, Population pharmacokinetics, Individualized administration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongyuan XuUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 5 Feb 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.
Propofol is a widely used sedative anesthetic, but there are large individual differences, which making different patients with different sensitivity to propofol. The aim of this study was to analyze the effects of age, height, body weight, Drinking, metabolic enzymes CYP2B6 and UGT1A9 on Pharmacological effects and pharmacokinetics of propofol, and to provide a reasonable reference for clinical anesthesia patients and evidence for individual dosage regimens.
Detailed description
Propofol is a widely used sedative anesthetic, but there are large individual differences, which making different patients with different sensitivity to propofol. In recent years, the concept of individualized administration came into being.Individual administration refers to according to the condition of patients,the drug's safety and efficacy, and pharmacokinetics, pharmacodynamics and clinical response ,then gives different dosing regimens for individual patients and promotes the development of rational drug use. Different people have differences metabolism of propofol, reported in the literature, genetic polymorphism, demographic characteristics, combined with drug and other variability factors, all of them will affect the pharmacokinetics and pharmacodynamics of propofol.The aim of this study was to analyze the effects of age, height, body weight, Drinking, metabolic enzymes CYP2B6 and UGT1A9 on Pharmacological effects and pharmacokinetics of propofol, and to provide a reasonable reference for clinical anesthesia patients and evidence for individual dosage regimens.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| External control | Experimental | Drug: Propofolpropofol;injection;2mg/kg;single-dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- patients aged 18-60 years (including those aged 18 and 60) who underwent gastrointestinal endoscopy;
- weight should not be less than (≥) 50kg, not more than (≤) 80kg. Body mass index (BMI) = body weight kg / [(height m) 2], in the normal range of 19 to 25;
- American Society of Anesthesiologists (ASA) grading (Appendix I): I or II;
- no heart, liver, lung, kidney, digestive tract, nervous system, mental disorders and other medical history, no blood and metabolic diseases and other medical history, no potential difficulties airway and special past history,
- blood, urine, stool routine, liver and kidney function, blood lipids, ECG, chest X-ray and blood pressure normal, or abnormal but no clinical significance, the researchers believe that can be grouped.
Key exclusion criteria (14 listed)
- important organs have primary disease;
- persons with mental or physical disabilities;
- those suffering from neurological or mental illness, a history of epilepsy;
- patients with cardiovascular or respiratory insufficiency and hypovolemia;
- obese or those with dyslipidemia;
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 |
|---|---|---|
| Propofolinjection;2mg/kg;single-dose | Drug | External control |
Primary outcome
BIS
Time frame: 210min
bispectral index monitoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Background: PubMed 21869535Kansaku F, Kumai T, Sasaki K, Yokozuka M, Shimizu M, Tateda T, Murayama N, Kobayashi S, Yamazaki H. Individual differences in pharmacokinetics and pharmacodynamics of anesthetic agent propofol with regard to CYP2B6 and UGT1A9 genotype and patient age. Drug Metab Pharmacokinet. 2011;26(5):532-7. doi: 10.2133/dmpk.dmpk-11-rg-039. Epub 2011 Aug 23.
- Background: PubMed 15258099Bernard O, Guillemette C. The main role of UGT1A9 in the hepatic metabolism of mycophenolic acid and the effects of naturally occurring variants. Drug Metab Dispos. 2004 Aug;32(8):775-8. doi: 10.1124/dmd.32.8.775.
- Background: PubMed 18816295Takahashi H, Maruo Y, Mori A, Iwai M, Sato H, Takeuchi Y. Effect of D256N and Y483D on propofol glucuronidation by human uridine 5'-diphosphate glucuronosyltransferase (UGT1A9). Basic Clin Pharmacol Toxicol. 2008 Aug;103(2):131-6. doi: 10.1111/j.1742-7843.2008.00247.x.
- Background: PubMed 24891132Khan MS, Zetterlund EL, Green H, Oscarsson A, Zackrisson AL, Svanborg E, Lindholm ML, Persson H, Eintrei C. Pharmacogenetics, plasma concentrations, clinical signs and EEG during propofol treatment. Basic Clin Pharmacol Toxicol. 2014 Dec;115(6):565-70. doi: 10.1111/bcpt.12277. Epub 2014 Jul 19.
- 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.
zhongyuan xu, Ph.D. study director
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with General Anesthesia, run by Zhongyuan Xu 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 6 inclusion and 14 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 9 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhongyuan xu, Ph.D. (13926186470 ext. 020-62787926, nfyygcp@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIS (time frame: 210min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422315, which also lists 4 linked publications.
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 9 Jun 2021.