Status:
UNKNOWN
Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection
Lead Sponsor:
Zhongyuan Xu
Conditions:
General Anesthesia
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
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 indiv...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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);
- 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.).
Key Trial Info
Start Date :
September 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03422315
Start Date
September 3 2018
End Date
September 1 2021
Last Update
June 9 2021
Active Locations (1)
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1
Nanfang Hospital，Southern Medical University
Guangzhou, Guangdong, China, 510515