Clinical trial NCT05518929: Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Ulcer
Gastric Cancer
Gastrointestinal Polyp
Keywords: Ciprofol
Gastroenterological Endoscope
Overweight
Obesity
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Tumor Hospital
name: Beijing Hospital
name: Second Hospital of Shanxi Medical University
name: Dalian Municipal Friendship Hospital
First posted: 2022-08-29
Enrollment: 1090
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, Randomized, Open-label, Propofol-controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hypoxia and severe hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: Incidence of hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Incidence of severe hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Incidence of subclinical respiratory depression
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Success rate of gastroenteroscopy endoscope
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Incidence of injection pain when the intravenous administration of Ciprofol or propofol for sedation assessed by questionnaire.
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Proportion of corrective hypoxic measures
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Zhejiang
country: China
facility: Zhejiang Tumor Hospital
state: Hangzhou
city: Dalian
country: China
facility: Dalian Municipal Friendship Hospital
state: Liaoning
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: Department of Anesthesiology Renji Hospital
name: Diansan Su
role: STUDY_DIRECTOR
References: