NCT06015074

Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP

Ciprofol vs Propofol for Reducing Hypoxia Incidence in Intravenous Anesthesia During Elective Endoscopic Retrograde Cholangiopancreatography-A Randomized Double Blinded Controlled Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Intravenous anesthesia has been widely used in endoscopic retrograde cholangiopancreatography (ERCP). In the past decade, many practices have been carried out under the propofol-based monitored anesthesia care without endotracheal intubation in patients undergoing ERCP. Ciprofol is a newly developed intravenous anesthetic with a potency 4-5 times than that of propofol. Ciprofol seems a promising anesthetic agent for intravenous anesthesia but the evidence supported its application in ERCP is still limited.

Detailed description

This is a prospective, randomized, double-blind trial comparing the incidence of hypoxia in the propofol versus ciprofol intravenous Anesthesia. A total 136 patients will be recruited and randomly assigned to either the propofol or the ciprofol group. The primary outcome is the proportion of patients experiencing hypoxia. The secondary outcomes include: the incidence of hypotension in perioperative period; the incidence of conversion from intravenous anesthesia to general anesthesia; sedation-related procedure interruption; carbon dioxide( CO2) accumulation during operation; Patients' satisfaction with anesthesia and postoperative recovery / VAS score / incidence of nausea and vomiting; the incidence of intraoperative and postoperative adverse events, such as adverse excretion, severe hypoxemia, severe circulatory dysfunction; length of stay and mortality within 30 days after operation.

Conditions

• Anesthesia; Adverse Effect
• Biliary Tract Diseases

Interventions

Type	Name	Description
DRUG	Propofol	patients in Propofol group receive sufentanil(0.1ug/kg)+ propofol (1.5-2mg/kg) for anesthesia induction, and continuous infusion of propofol 5mg/kg/h for anesthesia maintain.
DRUG	Ciprofol	patients in Ciprofol group receive sufentanil(0.1ug/kg)+ ciprofol(0.4-0.5mg/kg) for anesthesia induction, and continuous infusion of ciprofol 0.8mg/kg/h for anesthesia maintain.

Timeline

• Start date: 2024-06-15
• Primary completion: 2024-12-31
• Completion: 2025-02-28
• First posted: 2023-08-29
• Last updated: 2024-05-31

Locations

1 site across 1 country: China