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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastric Ulcer, Gastric Cancer, Gastrointestinal Polyp

Intervention / Treatment
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* Drug: Ciprofol
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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 Allergy to eggs, soy products, opioids and other drugs, propofol, etc. Participated in other clinical trials as a subject within 3 months Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits) 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. Patients who the investigator considers inappropriate to participate in this trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, Randomized, Open-label, Propofol-controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group(Propofol group)<br>Anesthesia induction:Propofol 1.5mg/kg Anesthesia maintenance: Propofol 0.75mg/kg | Drug: Propofol<br>* The sedation of gastrointestinal endoscopy with Propofol<br>|
| Experimental: Experimental group(ciprofol group)<br>Anesthesia induction:ciprofol 0.4mg/kg Anesthesia maintenance: ciprofol 0.2mg/kg | Drug: Ciprofol<br>* The sedation of gastrointestinal endoscopy with Ciprofol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoxia and severe hypoxia | hypoxia( 75%≤SpO2≤89% for<60s);severe hypoxia(SpO2<75%，or SpO2<90% for >60s) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoxia | hypoxia( 75%≤SpO2≤89% for<60s) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| Incidence of severe hypoxia | severe hypoxemia(SpO2<75%，or SpO2<90% for >60s) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| Incidence of subclinical respiratory depression | subclinical respiratory depression（90% ≤SpO2 ≤95% ） | 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 complain pain at the site of injection or tell investigators feeling pain when they were asked before they lose consciousness. | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| Proportion of corrective hypoxic measures | Treatment of patients with hypoxia | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ciprofol, Gastroenterological Endoscope, Overweight, Obesity