Gastric Cancer, Gastric Ulcer, Intestinal Cancer, Intestinal Polyps
Conditions
Keywords
sedation, gastrointestinal endoscopy, obese patient, ciprofol
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.
Interventions
DRUGciprofol
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).
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary Contactdiansan su, PhD
Outcome results
None listed