Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Effectiveness of sedation using dexmedetomidine and ketamine to facilitate non-invasive ventilation sessions which improve overall outcome after blunt chest trauma
Chest trauma remains an issue for health services for both severe and apparently mild trauma management. Severe chest trauma is associated with high mortality and is considered liable for 25% of mortality in multiple traumas. Moreover, mild trauma is also associated with significant morbidity especially in patients with preexisting conditions. Thus, whatever the severity, a fast-acting strategy must be organized.
Blunt traumas are commonly secondary to motor vehicle accidents, falls, and crush or blast injuries. They are the most common type of thoracic trauma, accounting for over 90%, and are often associated with rib fractures, haemothorax, pneumothorax, and pulmonary contusions.
In order to improve the prognosis of patients with severe chest trauma, early and continuous application of non-invasive mechanical ventilation (NIV) can indeed reduce the need for intubation and shorten intensive care unit length-of-stay Among different mechanisms, the early use of positive end-expiratory pressure after chest trauma, when feasible, seems mandatory to optimize oxygenation and improve clinical outcomes. Indeed, interventions aimed at preventing acute respiratory distress syndrome (ARDS) after chest trauma carry the greatest potential to reduce the substantial morbidity, mortality, and resource utilization associated with this syndrome.
Notably, pain control seems a crucial endpoint in our success to deliver non-invasive ventilation to patients with chest trauma, when feasible as a pivotal component of patient care after chest trauma, along with non-invasive ventilation. In this context, the role of intensivist doctors is thus to provide optimal control of chest wall pain, respiratory comfort, agitation, and anxiety as a prerequisite to reduce the incidence of NIV failure in this trauma population.
In this context, dexmedetomidine could be an alternative to improve NIV tolerance. Dexmedetomidine is a short-acting alpha-2 adrenoreceptor agonist that provides sedation and analgesia with no significant respiratory depression and a reduced risk of delirium.
Ketamine has several advantages compared with conventional sedatives such as preserving pharyngeal and laryngeal protective reflexes, lowering airway resistance, increasing lung compliance, and being less likely to produce respiratory depression. It causes sympathetic stimulation, which is also unlike other sedatives and analgesics.
However, no studies have estimated the superiority of dexmedetomidine or Ketamine to improve analgesia and non-invasive ventilation tolerance in patients with blunt chest
The patients will be randomly allocated into 3 groups, the allocation of the treatment order will determine by means of a computer-generated random table.
Group C: will receive placebo infusion (0.9% sodium chloride solution) Group D: will receive dexmedetomidine infusion Group K: will receive ketamine infusion
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | patients will receive two NIV sessions during which intravenous continuous infusion of dexmedetomidine will be given. The infusion was initiated 60 min prior to NIV at the same rate for all treatments, corresponding to 0.7 mcg/kg/h of dexmedetomidine without a loading dose. Dexmedetomidine will then titrate by 0.2 mcg/kg/h every 60 min (up to a maximum dose of 1.3 mcg/kg/h) to maintain a RASS score between 0 and 3. A 6-h washout period was observed between two NIV sessions accounting for 1-h contextual half-life of dexmedetomidine. Patients received neither tested drug nor NIV during this 6-h interval. |
|
| Ketamine | Active Comparator | patients will receive two NIV sessions during which intravenous continuous infusion of ketamine will be given. The infusion was initiated 60 min prior to NIV at the same rate for all treatments, infusion of ketamine will be at the dose of 0.20 mg/kg/h (or 3.3 mg/kg/min). to maintain a RASS score between 0 and 3. A 6-h washout period was observed between two NIV sessions . Patients received neither tested drug nor NIV during this 6-h interval. Following the start of the infusion, the patient could have a morphine dose if the 10-cm Visual Analog Scale (VAS) exceeded 3. |
|
| Placebo | Placebo Comparator | patients will receive two NIV sessions during which intravenous continuous infusion of placebo (0.9% sodium chloride solution) will be given. The infusion was initiated 60 min prior to NIV at the same rate for all treatments, corresponding to 0.7 mcg/kg/h of dexmedetomidine without a loading dose. will then titrate by 0.2 mcg/kg/h every 60 min (up to a maximum dose of 1.3 mcg/kg/h) to maintain a RASS score between 0 and 3. A 6-h washout period was observed between two . Patients received neither tested drug nor NIV during this 6-h interval. Following the start of any infusion, the patient could have a morphine dose if the 10-cm Visual Analog Scale (VAS) exceeded 3. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Hydrochloride | Drug | is a sympatholytic drug that acts as an agonist of α2-adrenergic receptors in certain parts of the brain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of non-invasive ventilation (NIV) session | duration that patient can withhold NIV comfortably | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Richmond agitation sedation score (RASS) | The hourly measurements by nurses of RASS score for pain and respiratory discomfort during each NIV session. | 8 hours |
| Visual analogue scale | the hourly measurements of self-rated 10-cm VAS for pain during each NIV session. |
Not provided
Inclusion Criteria:
All blunt chest trauma patients with:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHU | Aswān | 81511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31319192 | Background | Deletombe B, Trouve-Buisson T, Godon A, Falcon D, Giorgis-Allemand L, Bouzat P, Bosson JL, Payen JF. Dexmedetomidine to facilitate non-invasive ventilation after blunt chest trauma: A randomised, double-blind, crossover, placebo-controlled pilot study. Anaesth Crit Care Pain Med. 2019 Oct;38(5):477-483. doi: 10.1016/j.accpm.2019.06.012. Epub 2019 Jul 15. | |
| 28096063 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013898 | Thoracic Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ketamine Hydrochloride | Drug | Ketamine is an NMDA receptor antagoni |
|
|
| Placebo | Drug | Normal saline |
|
|
| 8 hours |
| length of ICU stay | Through study completion, an average of 1 year | 8 days |
| Bouzat P, Raux M, David JS, Tazarourte K, Galinski M, Desmettre T, Garrigue D, Ducros L, Michelet P; Expert's group; Freysz M, Savary D, Rayeh-Pelardy F, Laplace C, Duponq R, Monnin Bares V, D'Journo XB, Boddaert G, Boutonnet M, Pierre S, Leone M, Honnart D, Biais M, Vardon F. Chest trauma: First 48hours management. Anaesth Crit Care Pain Med. 2017 Apr;36(2):135-145. doi: 10.1016/j.accpm.2017.01.003. Epub 2017 Jan 16. |
| 27481750 | Background | Erstad BL, Patanwala AE. Ketamine for analgosedation in critically ill patients. J Crit Care. 2016 Oct;35:145-9. doi: 10.1016/j.jcrc.2016.05.016. Epub 2016 May 25. |
| 28105598 | Background | Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017 Aug;56(8):893-913. doi: 10.1007/s40262-017-0507-7. |
| 31076142 | Background | Jabaudon M, Blondonnet R, Constantin JM. ARDS in patients with chest trauma: Better safe than sorry. Anaesth Crit Care Pain Med. 2019 Jun;38(3):221-222. doi: 10.1016/j.accpm.2019.04.006. No abstract available. |
| 23575437 | Background | Mion G, Villevieille T. Ketamine pharmacology: an update (pharmacodynamics and molecular aspects, recent findings). CNS Neurosci Ther. 2013 Jun;19(6):370-80. doi: 10.1111/cns.12099. Epub 2013 Apr 10. |
| 21812509 | Background | Hoy SM, Keating GM. Dexmedetomidine: a review of its use for sedation in mechanically ventilated patients in an intensive care setting and for procedural sedation. Drugs. 2011 Jul 30;71(11):1481-501. doi: 10.2165/11207190-000000000-00000. |
| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |