The Incidences Of Hypoxia And Severe Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol Compared With Propofol In Overweight Or Obesity Adults Patients, A Multicenter, Randomized, Controlled Trial
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- RenJi Hospital
- Enrollment
- 1,090
- Locations
- 5
- Primary Endpoint
- Incidence of hypoxia and severe hypoxia
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •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
- •There is an uncontrolled disease history with significant clinical significance, such as liver, kidney, blood system, nervous system or metabolic system, which may not be suitable for participating in the study
- •Pregnant or breast-feeding women
Arms & Interventions
Control group(Propofol group)
Anesthesia induction:Propofol 1.5mg/kg Anesthesia maintenance: Propofol 0.75mg/kg
Intervention: Propofol (Drug)
Experimental group(ciprofol group)
Anesthesia induction:ciprofol 0.4mg/kg Anesthesia maintenance: ciprofol 0.2mg/kg
Intervention: Ciprofol (Drug)
Outcomes
Primary Outcomes
Incidence of hypoxia and severe hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
hypoxia( 75%≤SpO2≤89% for\<60s);severe hypoxia(SpO2\<75%，or SpO2\<90% for \>60s)
Secondary Outcomes
- Incidence of hypoxia(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Incidence of subclinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Success rate of gastroenteroscopy endoscope(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Incidence of injection pain when the intravenous administration of Ciprofol or propofol for sedation assessed by questionnaire.(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Proportion of corrective hypoxic measures(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)