Ciprofol Versus Propofol for Tracheal Intubation in ICU

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.

Study Overview

• Status: Completed
• Conditions: Emergency Tracheal Intubation in Critically Ill Patients
• Intervention / Treatment: Drug: Ciprofol; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital Affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol Group	Drug: Propofol; The sedation before tracheal intubation with Propofol
Experimental: Ciprofol Group	Drug: Ciprofol; The sedation before tracheal intubation with Ciprofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of sedation	Success rate of sedation	30 minutes from the the intubation procedure
Successful intubation on the first attempt	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)	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	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	The incidence of bradycardia within 30 minutes after tracheal intubation	30 minutes from the the intubation procedure
The incidence of hypoxemia within 30 minutes after tracheal intubation	The incidence of hypoxemia within 30 minutes after tracheal intubation	30 minutes from the the intubation procedure
new requirement or increase of vasopressors	new requirement or increase of vasopressors	30 minutes from the the intubation procedure
new requirement or increase of antiarrhythmic drugs	new requirement or increase of antiarrhythmic drugs	30 minutes from the the intubation procedure
Length of ICU stay and treatment outcome	Length of ICU stay and treatment outcome	From the start of randomization until patients were transferred out of the ICU or discharged
28 days without mechanical ventilation	28 days without mechanical ventilation	From the beginning of patients enrolled to 28 days after enrollment
28-day mortality rate	28-day mortality rate	within 28 days

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Actual): October 13, 2025
• Study Completion (Actual): October 13, 2025

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Critical Illness; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol
• Other Study ID Numbers: B2024-074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No