Ciprofol Versus Propofol for Tracheal Intubation in ICU

NCT06344949 | Completed Phase 4

• 1 other identifier: B2024-074
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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.

  30 minutes from the the intubation procedure

Secondary Outcomes (11)

• Success rate of sedation

  30 minutes from the the intubation procedure

• Successful intubation on the first attempt

  30 minutes from the the intubation procedure

• 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)

• The incidence of cardiac arrest within 30 minutes after tracheal intubation

  30 minutes from the the intubation procedure

• The incidence of bradycardia within 30 minutes after tracheal intubation

  30 minutes from the the intubation procedure

Study Arms (2)

Ciprofol Group

EXPERIMENTAL

Drug: Ciprofol

Propofol Group

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Ciprofol DRUG

The sedation before tracheal intubation with Ciprofol

Ciprofol Group

Propofol DRUG

The sedation before tracheal intubation with Propofol

Propofol Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (9)

• 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.

  PMID: 36045781 BACKGROUND

• 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.

  PMID: 35433310 BACKGROUND

• 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.

  PMID: 26084896 BACKGROUND

• 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.

  PMID: 30706173 BACKGROUND

• 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.

  PMID: 24536033 BACKGROUND

• 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.

  PMID: 35157236 BACKGROUND

• 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.

  PMID: 36618929 BACKGROUND

• 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.

  PMID: 35922771 BACKGROUND

• 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.

  PMID: 36647565 BACKGROUND

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: April 3, 2024
• Study Start: November 14, 2024
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)