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Completed

NCT Number: NCT06344949

Ciprofol Versus Propofol for Tracheal Intubation in ICU

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.

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Key information

Conditions

Emergency Tracheal Intubation in Critically Ill Patients

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ciprofol

Drug

The sedation before tracheal intubation with Ciprofol

Propofol

Drug

The sedation before tracheal intubation with Propofol

Primary outcomes

  1. cardiovascular collapse within 30minutes from the start of the intubation procedure

    Time frame: 30 minutes from the the intubation procedure

    defined as occurrence of at least one of the following events: systolic blood pressure<65 mm Hg recorded at least once; systolic blood pressure<90 mm Hg for>30 minutes; SBP decreased more than 20% from baseline;new requirement for, or increase of vasopressors.

Secondary outcomes

  1. Success rate of sedation

    Time frame: 30 minutes from the the intubation procedure

    Success rate of sedation

  2. Successful intubation on the first attempt

    Time frame: 30 minutes from the the intubation procedure

    Successful intubation on the first attempt

  3. Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes)

    Time frame: Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes)

    Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes)

  4. The incidence of cardiac arrest within 30 minutes after tracheal intubation

    Time frame: 30 minutes from the the intubation procedure

    The incidence of cardiac arrest within 30 minutes after tracheal intubation

  5. The incidence of bradycardia within 30 minutes after tracheal intubation

    Time frame: 30 minutes from the the intubation procedure

    The incidence of bradycardia within 30 minutes after tracheal intubation

  6. The incidence of hypoxemia within 30 minutes after tracheal intubation

    Time frame: 30 minutes from the the intubation procedure

    The incidence of hypoxemia within 30 minutes after tracheal intubation

  7. new requirement or increase of vasopressors

    Time frame: 30 minutes from the the intubation procedure

    new requirement or increase of vasopressors

  8. new requirement or increase of antiarrhythmic drugs

    Time frame: 30 minutes from the the intubation procedure

    new requirement or increase of antiarrhythmic drugs

  9. Length of ICU stay and treatment outcome

    Time frame: From the start of randomization until patients were transferred out of the ICU or discharged

    Length of ICU stay and treatment outcome

  10. 28 days without mechanical ventilation

    Time frame: From the beginning of patients enrolled to 28 days after enrollment

    28 days without mechanical ventilation

  11. 28-day mortality rate

    Time frame: within 28 days

    28-day mortality rate

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.