Clinical trial NCT06344949: Ciprofol Versus Propofol for Tracheal Intubation in ICU
Official title: Ciprofol Versus Propofol for Tracheal Intubation in ICU Patients: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Emergency Tracheal Intubation in Critically Ill Patients
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: cardiovascular collapse within 30minutes from the start of the intubation procedure
timeFrame: 30 minutes from the the intubation procedure
Secondary outcomes:
measure: Success rate of sedation
timeFrame: 30 minutes from the the intubation procedure
measure: Successful intubation on the first attempt
timeFrame: 30 minutes from the the intubation procedure
measure: Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes)
timeFrame: Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes)
measure: The incidence of cardiac arrest within 30 minutes after tracheal intubation
timeFrame: 30 minutes from the the intubation procedure
measure: The incidence of bradycardia within 30 minutes after tracheal intubation
timeFrame: 30 minutes from the the intubation procedure
measure: The incidence of hypoxemia within 30 minutes after tracheal intubation
timeFrame: 30 minutes from the the intubation procedure
measure: new requirement or increase of vasopressors
timeFrame: 30 minutes from the the intubation procedure
measure: new requirement or increase of antiarrhythmic drugs
timeFrame: 30 minutes from the the intubation procedure
measure: Length of ICU stay and treatment outcome
timeFrame: From the start of randomization until patients were transferred out of the ICU or discharged
measure: 28 days without mechanical ventilation
timeFrame: From the beginning of patients enrolled to 28 days after enrollment
measure: 28-day mortality rate
timeFrame: within 28 days
Other outcomes:
Locations:
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.