Sedation for Non-invasive Ventilation in Blunt Chest Trauma

NCT05175781 | Completed

• 1 other identifier: 494/12/20
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Effectiveness of sedation using dexmedetomidine and ketamine to facilitate non-invasive ventilation sessions which improve overall outcome after blunt chest trauma

Conditions

Chest Trauma

Keywords

Sedation - noninvasive ventilation-ketamine- dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Duration of non-invasive ventilation (NIV) session

  duration that patient can withhold NIV comfortably

  8 hours

Secondary Outcomes (3)

• Richmond agitation sedation score (RASS)

  8 hours

• Visual analogue scale

  8 hours

• length of ICU stay

  8 days

Study Arms (3)

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.

Drug: Dexmedetomidine Hydrochloride

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.

Drug: Ketamine Hydrochloride

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.

Drug: Placebo

Interventions

Dexmedetomidine Hydrochloride DRUG

is a sympatholytic drug that acts as an agonist of α2-adrenergic receptors in certain parts of the brain.

Also known as: Precedex

Dexmedetomidine

Ketamine Hydrochloride DRUG

Ketamine is an NMDA receptor antagoni

Also known as: Ketalar

Ketamine

Placebo DRUG

Normal saline

Also known as: Nacl .9%

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All blunt chest trauma patients with:
• More than 3 rib fractures, pulmonary contusion,
• hypoxemia or hypercapnia, or respiratory rate 20/ min despite an optimized intravenous analgesia ( paracetamol 1gm i.v. 6hourly and ketolac 30mg i.v. 8 hourly)
• No indication of mechanical ventilation

You may not qualify if:

• Patients \< 18 years old,
• admitted under mechanical ventilation
• admitted more than 24 h after trauma or from another hospital,
• patients with less than 3 ribs fractures
• patients did not receive CT-scan
• Patients in whom alpha-2 agonists or ketamine are contraindicated
• Patients who will require an intubation during the study period for a life-threatening condition or emergency surgery or agitation as defined by a Richmond Agitation Sedation Scale (RASS) score higher than +2 will also excluded.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

AHU

Aswān, 81511, Egypt

Location

Related Publications (7)

• 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.

  PMID: 31319192 BACKGROUND

• 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.

  PMID: 28096063 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.

  PMID: 27481750 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.

  PMID: 28105598 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.

  PMID: 31076142 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.

  PMID: 23575437 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.

  PMID: 21812509 BACKGROUND

MeSH Terms

Conditions

Thoracic Injuries

Interventions

Dexmedetomidine; Ketamine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, anaesthesia and ocu department, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 7, 2021
• First Posted: January 4, 2022
• Study Start: January 18, 2022
• Primary Completion: July 20, 2022
• Study Completion: July 26, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

EG (1)