Ciprofol Versus Propofol for Tracheal Intubation in ICU

NCT ID: NCT06344949

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-14
• Study Completion Date: 2025-10-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ciprofol Group

Group Type: EXPERIMENTAL

Ciprofol

Intervention Type: DRUG

The sedation before tracheal intubation with Ciprofol

Propofol Group

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

The sedation before tracheal intubation with Propofol

Interventions

Ciprofol

The sedation before tracheal intubation with Ciprofol

Intervention Type: DRUG

Propofol

The sedation before tracheal intubation with Propofol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients who are allergic to the study drugs, or patients with contraindications to the study drugs;
• Patients with difficult airways (MACOCHA ≥ 3 points);
• Patients who require emergency intubation due to sudden cardiac arrest;
• Patients who require conscious intubation;
• Patients who can maintain mean arterial pressure (MAP) above 65mmHg using of one or more vasoactive drugs (equivalent (-)-noradrenaline > 0.3 μg kg min);
• In a state of imminent death;
• Pregnant and/or lactating women; Subject judged by the investigator to have any other factors unsuitable for participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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Other Identifiers

B2024-074

Identifier Type: -

Identifier Source: org_study_id