Ciprofol, Hypoproteinemia, Pharmacokinetics
Conditions
Brief summary
Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia
Detailed description
This study was a single-center, interventional clinical study. Patients with different plasma albumin levels were selected before surgery and induced by a single injection of Ciprofol at a depth of 0.3 mg/kg. 2ml of venous blood was collected before and 0.5, 1, 2, 3, 5, 8, 15, 30min, 1h, 2h and 4h after administration. The pharmacokinetics of Ciprofol were studied by measuring the concentration of Ciprofol in blood.
Interventions
DRUGciprofol
Patients who intended to undergo elective surgery under general anesthesia were induced by a single intravenous injection of 0.3mg/kg and ciprofol, and the experimental drug was manually injected by CVC within 30s. 2ml of venous blood was collected before and after administration 0.5min, 1min, 2min, 3min, 5min, 8min, 15min 30min, 1h, 2h and 4h respectively. The concentration of cyclopofol in blood was measured
Sponsors
Xie Kangjie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with moderate to severe hypoproteinemia (albumin \< 30g/L, protein detection time uniformly within three days before surgery） * Weight greater than 45kg, BMI20-24 * The ASA rating is Class I or Class II
Exclusion criteria
* Severe liver dysfunction * Severe renal dysfunction * Patients with ASA grade III and above * Known allergy to eggs, soy products, opioids and their relief drugs, propofol * Emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood concentrations at different time points after a single injection | Before administration, after administration 0.5 minute, 1 minute, 2 minutes, 3 minutes, 5 minutes, 8 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours | Blood concentration of ciprofol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect time of ciprofol in patients with hypoproteinemia | Day 1 | From the time the drug was administered to the time the patient lost consciousness |
| Onset time of ciprofol in patients with hypoproteinemia | Day 1 | The time it takes for the blood concentration of a drug to reach the clinically active concentration level from zero |
Countries
China
Outcome results
None listed