Gastric Cancer, Gastric Ulcer, Gastrointestinal Polyp
Conditions
Keywords
Ciprofol, Gastroenterological Endoscope, Overweight, Obesity
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.
Interventions
DRUGCiprofol
The sedation of gastrointestinal endoscopy with Ciprofol
DRUGPropofol
The sedation of gastrointestinal endoscopy with Propofol
Sponsors
Zhejiang Tumor Hospital
Beijing Hospital
Second Hospital of Shanxi Medical University
Dalian Municipal Friendship Hospital
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, Randomized, Open-label, Propofol-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoxia and severe hypoxia | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe hypoxia | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | severe hypoxemia(SpO2\<75%，or SpO2\<90% for \>60s) |
| Incidence of subclinical respiratory depression | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | subclinical respiratory depression（90% ≤SpO2 ≤95% ） |
| Incidence of hypoxia | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | hypoxia( 75%≤SpO2≤89% for\<60s) |
| 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 | Patients complain pain at the site of injection or tell investigators feeling pain when they were asked before they lose consciousness. |
| Proportion of corrective hypoxic measures | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | Treatment of patients with hypoxia |
| Success rate of gastroenteroscopy endoscope | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | — |
Countries
China
Outcome results
None listed