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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol Group | Experimental |
| |
| Propofol Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol | Drug | The sedation before tracheal intubation with Ciprofol |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36045781 | Background | 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. | |
| 35433310 | Background |
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| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol |
| Drug |
The sedation before tracheal intubation with Propofol |
|
| 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 |
| 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. |
| 26084896 | 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. |
| 30706173 | 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. |
| 24536033 | 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. |
| 35157236 | 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. |
| 36618929 | 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. |
| 35922771 | 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. |
| 36647565 | 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. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |