Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection

NCT03422315 | Unknown DMC

• 1 other identifier: C1033453
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 pharmacokinetics of propofol, and to provide a reasonable reference for clinical anesthesia patients and evidence for individual dosage regimens.

Conditions

General Anesthesia

Keywords

Propofol; Population pharmacokinetics; Individualized administration

Outcome Measures

Primary Outcomes (1)

• BIS

  bispectral index monitoring

  210min

Study Arms (1)

External control

EXPERIMENTAL

propofol;injection;2mg/kg;single-dose

Drug: Propofol

Interventions

Propofol DRUG

injection;2mg/kg;single-dose

External control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);
• 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.).

Sponsors & Collaborators

• Zhongyuan Xu: lead

Study Sites (1)

Nanfang Hospital，Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 21869535 BACKGROUND

• Bernard 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.

  PMID: 15258099 BACKGROUND

• Takahashi 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.

  PMID: 18816295 BACKGROUND

• Khan 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.

  PMID: 24891132 BACKGROUND

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• zhongyuan xu, Ph.D.

  Nanfang Hospital, Southern Medical University

  STUDY DIRECTOR

Central Study Contacts

zhongyuan xu, Ph.D.

CONTACT

13926186470; nfyygcp@126.com

wanwen cao, master

CONTACT

13631304126; nfyygcp@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of GCP Office

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: February 5, 2018
• Study Start: September 3, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)