NCT06344949

Ciprofol Versus Propofol for Tracheal Intubation in ICU

Ciprofol Versus Propofol for Tracheal Intubation in ICU Patients: a Randomized Controlled Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The physiological reserves of critically ill patients are relatively low, and the risk of complications related to tracheal intubation in the ICU is higher than in the operating room. ICU tracheal intubation complications account for approximately 40% -45% of patients, including severe hypotension (10% -43%), severe hypoxemia (9% -25%), and cardiac arrest (2% -3%).Ciprofol is a novel 2,6-disubstituted phenol derivative that targeting γ-aminobutyric acid type A (GABAA)-receptor. There are four indications of ciprofol that have been approved by NMPA in recent two years: sedation and anesthesia in non-tracheal intubation procedure/operation, induction and maintenance of general anesthesia, sedation during intensive care, sedation and maintenance in gynecological outpatient surgery. The aim of this study is to compare the effects of propofol and propofol on the circulatory system during tracheal intubation in ICU patients, in order to provide a safer induction sedation regimen for emergency tracheal intubation in critically ill patients.

Conditions

• Emergency Tracheal Intubation in Critically Ill Patients

Interventions

Type	Name	Description
DRUG	Ciprofol	The sedation before tracheal intubation with Ciprofol
DRUG	Propofol	The sedation before tracheal intubation with Propofol

Timeline

• Start date: 2024-11-14
• Primary completion: 2025-10-13
• Completion: 2025-10-13
• First posted: 2024-04-03
• Last updated: 2025-11-21

Locations

1 site across 1 country: China