Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.

NCT ID: NCT05517408

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2023-08-13

Brief Summary

Ciprofol is a new anesthetic, which combines with γ- Aminobutyric acid-a (GABAA) receptor. Ciprofol has shown equivalent anesthetic efficacy of propofol at 1/4 to 1/5 of the dosage. Ciprofol has the pharmacodynamic characteristics of rapid onset, stable and rapid recovery. Phase III clinical results showed that the incidence of injection pain and respiratory and circulatory depression of ciprofol was lower than that of propofol. Therefore, ciprofol has a good application prospect in sedation for gastrointestinal endoscopy, especially for obese patients. In the current study, we would explore the proper dose of Ciprofol in sedated gastrointestinal endoscopy in obese patients.

Conditions

Gastric Cancer; Gastric Ulcer; Intestinal Polyps; Intestinal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ciprofol group

Group Type: EXPERIMENTAL

ciprofol

Intervention Type: DRUG

The first patient received Ciprofol 0.3mg/kg (actual body weight) at a rate of 1 mg/s. If the desired depth of sedation/anesthesia reached, then it was judged as negative, and the dose of Ciprofol in next patient would be decreased by one concentration gradient (the difference between two adjacent drugs was 1:1.1); If the desired sedation/anesthesia depth was not achieved, then it was judged as positive. And the dose of Ciprofol in next patient would be increased by one concentration gradient. Patients were enrolled consecutively until the trial was terminated at the eighth crossing point (positive to negative or negative to positive).

Interventions

ciprofol

The first patient received Ciprofol 0.3mg/kg (actual body weight) at a rate of 1 mg/s. If the desired depth of sedation/anesthesia reached, then it was judged as negative, and the dose of Ciprofol in next patient would be decreased by one concentration gradient (the difference between two adjacent drugs was 1:1.1); If the desired sedation/anesthesia depth was not achieved, then it was judged as positive. And the dose of Ciprofol in next patient would be increased by one concentration gradient. Patients were enrolled consecutively until the trial was terminated at the eighth crossing point (positive to negative or negative to positive).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age, ≤18 and ≤60 years, no gender limit

2. Undergoing routine gastrointestinal endoscopic diagnosis and treatment

3. American Society of Anesthesiologists (ASA) classification I-II

4. Body Mass Index(BMI) ≥28kg/m^2

5. Clearly understand and voluntarily participate in the study; provide signed informed consent

Exclusion Criteria

1. Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)

2. Drug abuse history within 3 months before the screening period

3. People who are known to be allergic to eggs, bean products, opioids and other drugs, propofol, etc

4. The researcher believes that patients should not participate in this trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renji Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

diansan su, PhD

Role: CONTACT

diansansu@yahoo.com

18616514088

Facility Contacts

diansan su, PhD

Role: primary

diansansu@yahoo.com

18616514088

Other Identifiers

diansansu0722

Identifier Type: -

Identifier Source: org_study_id