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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517408
• Other study ID #: diansansu0722
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: August 13, 2023

Study information

• Verified date: August 2023
• Source: RenJi Hospital
• Contact: diansan su, PhD
• Phone: 18616514088
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 13, 2023
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastric Ulcer
• Intestinal Cancer
• Intestinal Neoplasms
• Intestinal Polyps
• Stomach Ulcer

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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