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A randomized, controlled clinical study of Ciprofol Injectionfor sedation in gastroscopy combined with enteroscopy in overweight or obese patients

A randomized, controlled clinical study of Ciprofol Injection for sedation in gastroscopy combined with enteroscopy in overweight or obese patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062970
Enrollment
Unknown
Registered
2022-08-25
Start date
2022-08-15
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight or obese patients undergoing routine painless gastroscopy combined with enteroscopy

Interventions

Group Ciprofol: Ciprofol Injection
Group Propofol:Propofol Injection

Sponsors

shanghai jiaotong Univercity School of Medicine, Renji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old, = 80 years old, regardless of gender; 2. Patients undergoing elective gastroenteroscopy; 3. ASA is classified as level I or level II; 4. BMI=23kg/m2 5. It is estimated that the operation time of gastroenteroscopy will not exceed 30min; Clearly understand and voluntarily participate in the study, and sign the informed consent form by himself or his family.

Exclusion criteria

Exclusion criteria: 1. Endoscopic diagnosis and treatment techniques with complex operations are required (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, oral endoscopic muscle dissection, etc.); 2. Patients to be intubated; 3. SpO2 = 95% after entering the room; 4. Definitely diagnosed as sleep apnea syndrome; 5. Weight <40kg 6. Have serious heart diseases such as severe arrhythmia, heart failure, Alzheimer's syndrome, unstable angina pectoris, myocardial infarction in recent 6 months, history of tachycardia / bradycardia requiring drug treatment, third degree atrioventricular block or QTCF 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 infection within 1 week, and obvious symptoms such as fever, wheezing, nasal congestion and cough; 9. There is a history of uncontrolled diseases with significant clinical significance, such as liver, kidney, blood system, nervous system or metabolic system, which the researchers judge may not be suitable to participate in the study; 10. Pregnant or lactating women; 11. People who are known to be allergic to eggs, bean products, opioids and their rescue drugs, propofol, etc; 12. Participated in clinical trials of other drugs as subjects within 3 months; 13. Have a history of alcoholism within 3 months, i.e. drinking more than 2 units of alcohol per day (1 unit =360ml beer or 45ml Baijiu or 150ml wine with 40% alcohol); 14. Those with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm and cerebrovascular accident; Patients with schizophrenia, mental retardation, mania, insanity, long-term use of psychotropic drugs, drug addiction, history of cognitive dysfunction, etc; 15. The researcher believes that patients should not participate in this trial

Design outcomes

Primary

MeasureTime frame
BMI;SpO2;

Secondary

MeasureTime frame
Heart Rate;Breathe Rate;SpCO2;

Countries

China

Contacts

Public ContactWeifeng Yu
Ywf808@yeah.net+86 18368807197

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026