## Protocol Section
### Identification Module
**NCT ID:** NCT06425757

**Brief Title:** Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia

**Official Title:** Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia

#### Organization Study ID Info
**ID:** IRB-2024-315(IIT)
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Xie Kangjie

#### Responsible Party

**Investigator Affiliation:** Zhejiang Cancer Hospital

**Investigator Full Name:** Xie Kangjie

**Investigator Title:** Clinical Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hypoproteinemia

- Pharmacokinetics

- Ciprofol

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Blood albumin concentration≤30g/L

**Intervention Names:**

- Drug: ciprofol

**Label:** Severe Hypoproteinemia

**Type:** OTHER

#### Arm Group 2

**Description:** Blood albumin concentration 30g/L-40g/L

**Intervention Names:**

- Drug: ciprofol

**Label:** Moderate Hypoproteinemia

**Type:** OTHER

#### Arm Group 3

**Description:** Blood albumin concentration \>40g/L

**Intervention Names:**

- Drug: ciprofol

**Label:** Normal plasma albumin

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Moderate Hypoproteinemia

- Normal plasma albumin

- Severe Hypoproteinemia

**Description:** 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

**Name:** ciprofol

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Blood concentration of ciprofol

**Measure:** Blood concentrations at different time points after a single injection

**Time Frame:** 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

#### Secondary Outcomes

**Description:** The time it takes for the blood concentration of a drug to reach the clinically active concentration level from zero

**Measure:** Onset time of ciprofol in patients with hypoproteinemia

**Time Frame:** Day 1

**Description:** From the time the drug was administered to the time the patient lost consciousness

**Measure:** Effect time of ciprofol in patients with hypoproteinemia

**Time Frame:** Day 1

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** xiekj@zjcc.org.cn

**Name:** XIE Kangjie, doctoral

**Phone:** 13516721870

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Email:** xiekj@zjcc.org.cn

- **Name:** XIE Kangjie, MD

- **Phone:** 13516721870

- **Role:** CONTACT

**Country:** China

**Facility:** Zhejiang Cancer Hospital

**State:** Zhejang

**Status:** RECRUITING

**Zip:** 310000

#### Overall Officials

**Official 1:**

**Affiliation:** Zhejiang Cancer Hospital

**Name:** XIE Kangjie, doctoral

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001796

- Term: Blood Protein Disorders

- ID: D000006402

- Term: Hematologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10069

- Name: Hypoproteinemia

- Relevance: HIGH

- As Found: Hypoproteinemia

- ID: M5077

- Name: Blood Protein Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007019

- Term: Hypoproteinemia

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
