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Emergency Tracheal Intubation in Critically Ill PatientsPhase 4NCT06344949

Ciprofol Versus Propofol for Tracheal Intubation in ICU

A Phase 4 study testing Ciprofol and Propofol in people with Emergency Tracheal Intubation in Critically Ill Patients, run by Shanghai Zhongshan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Ciprofol and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
14 Nov 2024to 13 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

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

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.

Being tested
Ciprofol, Propofol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CiprofolDrug

    The sedation before tracheal intubation with Ciprofol

  • PropofolDrug

    The sedation before tracheal intubation with Propofol

Study groups in NCT06344949
Study groupRoleWhat they receive
Ciprofol GroupExperimentalNot described
Receives: Drug: Ciprofol
Propofol GroupActive comparatorNot described
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 minutes from the the intubation procedure

Secondary outcomes (11)

  1. Success rate of sedation

    Success rate of sedation

    Measured: 30 minutes from the the intubation procedure

  2. Successful intubation on the first attempt

    Successful intubation on the first attempt

    Measured: 30 minutes from the the intubation procedure

  3. 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)

    Measured: 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

    The incidence of cardiac arrest within 30 minutes after tracheal intubation

    Measured: 30 minutes from the the intubation procedure

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

    The incidence of bradycardia within 30 minutes after tracheal intubation

    Measured: 30 minutes from the the intubation procedure

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

    The incidence of hypoxemia within 30 minutes after tracheal intubation

    Measured: 30 minutes from the the intubation procedure

  7. new requirement or increase of vasopressors

    new requirement or increase of vasopressors

    Measured: 30 minutes from the the intubation procedure

  8. new requirement or increase of antiarrhythmic drugs

    new requirement or increase of antiarrhythmic drugs

    Measured: 30 minutes from the the intubation procedure

  9. Length of ICU stay and treatment outcome

    Length of ICU stay and treatment outcome

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

  10. 28 days without mechanical ventilation

    28 days without mechanical ventilation

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

  11. 28-day mortality rate

    28-day mortality rate

    Measured: within 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start14 Nov 2024
  3. Primary completion13 Oct 2025
  4. Study completion13 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06344949
Sponsor's protocol ID
B2024-074
Status last verified
Oct 2025
First submitted
1 Mar 2024
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Admass BA, Endalew NS, Tawye HY, Melesse DY, Workie MM, Filatie TD. Evidence-based airway management protocol for a critical ill patient in medical intensive care unit: Systematic review. Ann Med Surg (Lond). 2022 Aug 4;80:104284. doi: 10.1016/j.amsu.2022.104284. eCollection 2022 Aug.

    PubMed 36045781

  • Tarwade P, Smischney NJ. Endotracheal intubation sedation in the intensive care unit. World J Crit Care Med. 2022 Jan 9;11(1):33-39. doi: 10.5492/wjccm.v11.i1.33. eCollection 2022 Jan 9.

    PubMed 35433310

  • Perbet S, De Jong A, Delmas J, Futier E, Pereira B, Jaber S, Constantin JM. Incidence of and risk factors for severe cardiovascular collapse after endotracheal intubation in the ICU: a multicenter observational study. Crit Care. 2015 Jun 18;19(1):257. doi: 10.1186/s13054-015-0975-9.

    PubMed 26084896

  • Honore PM, De Bels D, Barreto Gutierrez L, Spapen HD. Hemoadsorption therapy in the critically ill: solid base but clinical haze. Ann Intensive Care. 2019 Jan 31;9(1):22. doi: 10.1186/s13613-019-0491-1. No abstract available.

    PubMed 30706173

  • Koenig SJ, Lakticova V, Narasimhan M, Doelken P, Mayo PH. Safety of Propofol as an Induction Agent for Urgent Endotracheal Intubation in the Medical Intensive Care Unit. J Intensive Care Med. 2015 Dec;30(8):499-504. doi: 10.1177/0885066614523100. Epub 2014 Feb 17.

    PubMed 24536033

  • Luo Z, Tu H, Zhang X, Wang X, Ouyang W, Wei X, Zou X, Zhu Z, Li Y, Shangguan W, Wu H, Wang Y, Guo Q. Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study. CNS Drugs. 2022 Mar;36(3):301-313. doi: 10.1007/s40263-021-00890-1. Epub 2022 Feb 14.

    PubMed 35157236

  • Wu B, Zhu W, Wang Q, Ren C, Wang L, Xie G. Efficacy and safety of ciprofol-remifentanil versus propofol-remifentanil during fiberoptic bronchoscopy: A prospective, randomized, double-blind, non-inferiority trial. Front Pharmacol. 2022 Dec 21;13:1091579. doi: 10.3389/fphar.2022.1091579. eCollection 2022.

    PubMed 36618929

  • Chen BZ, Yin XY, Jiang LH, Liu JH, Shi YY, Yuan BY. The efficacy and safety of ciprofol use for the induction of general anesthesia in patients undergoing gynecological surgery: a prospective randomized controlled study. BMC Anesthesiol. 2022 Aug 3;22(1):245. doi: 10.1186/s12871-022-01782-7.

    PubMed 35922771

  • Liang P, Dai M, Wang X, Wang D, Yang M, Lin X, Zou X, Jiang K, Li Y, Wang L, Shangguan W, Ren J, He H. Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial. Eur J Anaesthesiol. 2023 Jun 1;40(6):399-406. doi: 10.1097/EJA.0000000000001799. Epub 2023 Jan 19.

    PubMed 36647565

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ciprofol and Propofol in people with Emergency Tracheal Intubation in Critically Ill Patients, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cardiovascular collapse within 30minutes from the start of the intubation procedure (time frame: 30 minutes from the the intubation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06344949, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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