Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients (SpO2)

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Gastric Cancer; Gastric Ulcer; Gastrointestinal Polyp

Treatments: Drug: Propofol; Drug: Ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05518929

KY2022-155-B

Details and patient eligibility

About

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.

Enrollment: 1,090 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age, ≤18 and ≤80 years, no gender limit
2. Undergoing routine gastrointestinal endoscopic diagnosis and treatment
3. American Society of Aneshesiologists (ASA) classification I-II
4. Body mass index (BMI) ≥ 23kg/m2
5. Estimated procedure duration less than 30 min
6. Clearly understand and voluntarily participate in the study; provide signed informed consent

Exclusion criteria

1. 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
2. Intend to undergo tracheal intubation or laryngeal mask
3. Patients' SpO2 ≤ 95% after entering the endoscope room;
4. Be definitely diagnosed as obstructive sleep apnea hypopnea syndrome;
5. Body weight < 40kg
6. 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
7. Systolic blood pressure ≥ 180mmhg or / and diastolic blood pressure ≥ 110mmhg measured in the endoscope room
8. 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
9. 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
10. Pregnant or breast-feeding women
11. Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
12. Participated in other clinical trials as a subject within 3 months
13. Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)
14. Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc.
15. Patients who the investigator considers inappropriate to participate in this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,090 participants in 2 patient groups

Control group(Propofol group)

Active Comparator group

Description:

Anesthesia induction:Propofol 1.5mg/kg Anesthesia maintenance: Propofol 0.75mg/kg

Treatment:

Drug: Propofol

Experimental group(ciprofol group)

Experimental group

Description:

Anesthesia induction:ciprofol 0.4mg/kg Anesthesia maintenance: ciprofol 0.2mg/kg

Treatment:

Drug: Ciprofol