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

Not Applicable

Recruiting

• Conditions: Gastric Cancer; Intestinal Polyps; Intestinal Cancer; Gastric Ulcer
• Interventions: Drug: ciprofol

• Registration Number: NCT05517408
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2022-09-19
• Primary Completion: 2022-11-03
• Status Verified: 2023-08
• Study Completion: 2023-08-13
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ciprofol group	ciprofol	-

Primary Outcome Measures

Name	Time	Method
Calculating the the median effective dose (ED50) of ciprofol for sedation gastrointestinal endoscopy in obese patients.	Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary Outcome Measures

Name	Time	Method
Calculating the the ED95 of ciprofol for sedation gastrointestinal endoscopy in obese patients.	Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China