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Trial Title:
Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.
NCT ID:
NCT05517408
Condition:
Gastric Cancer
Gastric Ulcer
Intestinal Polyps
Intestinal Cancer
Conditions: Official terms:
Intestinal Neoplasms
Stomach Ulcer
Intestinal Polyps
Conditions: Keywords:
sedation
gastrointestinal endoscopy
obese patient
ciprofol
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ciprofol
Description:
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).
Arm group label:
Ciprofol group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
diansan su, PhD
Phone:
18616514088
Email:
diansansu@yahoo.com
Start date:
September 19, 2022
Completion date:
August 13, 2023
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05517408
