Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Ob… (NCT05518929) | Clinical Trial Compass
CompletedPhase 4
Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients
China1,090 participantsStarted 2022-09-08
Plain-language summary
Ciprofol is a new general anesthetic, which combine 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 the sedation for gastrointestinal endoscopy, especially for overweight and obese patients. We conduct a Multicenter, Randomized, Open-label, Propofol-controlled Study to Evaluate the incidence of hypoxia and severe hypoxia during Gastroenterological Endoscope sedated with CiProfol in Overweight or Obesity patients.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age, ≤18 and ≤80 years, no gender limit
✓. Undergoing routine gastrointestinal endoscopic diagnosis and treatment
✓. American Society of Aneshesiologists (ASA) classification I-II
✓. Body mass index (BMI) ≥ 23kg/m2
✓. Estimated procedure duration less than 30 min
✓. Clearly understand and voluntarily participate in the study; provide signed informed consent
Exclusion criteria
✕. Need to perform complicated endoscopic techniques for diagnosis and treatment, such as cholangiopancreatography surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa stripping, and oral endoscopic muscle dissection
✕. Intend to undergo tracheal intubation or laryngeal mask
✕. Patients' SpO2 ≤ 95% after entering the endoscope room;
✕
What they're measuring
1
Incidence of hypoxia and severe hypoxia
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
. Be definitely diagnosed as obstructive sleep apnea hypopnea syndrome;
✕. Body weight \< 40kg
✕. Have serious heart diseases such as severe arrhythmia, heart failure, Adams-Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance \< 4mets
✕. Systolic blood pressure ≥ 180mmhg or / and diastolic blood pressure ≥ 110mmhg measured in the endoscope room
✕. Respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months, acute respiratory tract infection within 1 week, and obvious symptoms such as fever, wheezing, nasal congestion and cough