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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Patients who need to undergo tracheal intubation under sedation after entering the ICU;

• Age range from 18 to 85 years old;

• Patients or their families have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign an informed consent form.

Locations
Other Locations
China
Zhongshan Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Han Fei Attending physician
han.fei@zs-hospital.sh.cn
18801736007
Time Frame
Start Date: 2024-11-14
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Ciprofol Group
Active_comparator: Propofol Group
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov