Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-04

Study Completion Date

2025-08-30

Brief Summary

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Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia

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Detailed Description

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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.

Conditions

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Hypoproteinemia Pharmacokinetics Ciprofol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Severe Hypoproteinemia

Blood albumin concentration≤30g/L

Group Type OTHER

ciprofol

Intervention Type DRUG

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

Moderate Hypoproteinemia

Blood albumin concentration 30g/L-40g/L

Group Type OTHER

ciprofol

Intervention Type DRUG

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

Normal plasma albumin

Blood albumin concentration \>40g/L

Group Type OTHER

ciprofol

Intervention Type DRUG

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

Interventions

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ciprofol

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

Intervention Type DRUG

Other Intervention Names

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Si Shuning

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes