Clinical trial · Interventional
Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Ulcer | — | UNRESOLVED | — |
| Gastrointestinal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ciprofol | Drug | — | UNRESOLVED |
| Propofol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group(Propofol group)
- description
- Anesthesia induction:Propofol 1.5mg/kg Anesthesia maintenance: Propofol 0.75mg/kg
- interventionNames
- Drug: Propofol
- type
- EXPERIMENTAL
- label
- Experimental group(ciprofol group)
- description
- Anesthesia induction:ciprofol 0.4mg/kg Anesthesia maintenance: ciprofol 0.2mg/kg
- interventionNames
- Drug: Ciprofol
Primary outcomes (1)
- measure
- Incidence of hypoxia and severe hypoxia
- timeFrame
- Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhou R, Dai W, Su Z, Lian Y, Wen P, Zhang L, Kong L, Hua Z, Sun Y, Zhao H, Wang Q, Yu W, Su D. Ciprofol Versus Propofol for the Prevention of Hypoxia During Gastrointestinal Endoscopy Procedures in Overweight Patients: A Multicenter, Randomized, Controlled Trial. Dig Endosc. 2026 Feb;38(2):e70102. doi: 10.1111/den.70102. PMID 41626789