Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients

Trauma Clinical Trial

— DEXsedation  

Official title:

Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606409
• Other study ID #: IRB00008718/1548
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 12, 2015
• Last updated: August 20, 2016
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

Dexmedetomidine, a central and peripheral α2-receptor agonist distinct from GABA receptor for benzodiazepines and propofol, has been approved by the US Food and Drug Administration only for use up to 24 h in mechanically ventilated patients. The investigators aim to compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated patients.

Description:

The importance of optimizing the levels of sedation in critical care has been increasingly recognized. Many intensive care experts are focusing on maintaining a targeted ''ideal'' sedation level according to the individual patient's condition to avoid adverse events such as prolonged mechanical ventilation, respiratory depression, pneumonia, delirium, psychological problems, and increased treatment costs resulting from over sedation. Dexmedetomidine is a selective alpha-2-adrenoceptor agonist. It exerts both sedative and analgesic effects via mechanisms different from other sedatives such as midazolam and propofol, and provides sedation characterized by prompt response to stimuli with no respiratory depression. The investigators aim to compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated patients. The investigators will perform a prospective, single center trial to investigate the safety and efficacy of dexmedetomidine for long-term sedation in poly traumatized mechanically ventilated ICU patients, in comparison with propofol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Endotracheal Intubation

• Mechanical ventilation

• Poly traumatized

• ICU patients and estimated duration of sedation>24 h.

Exclusion Criteria:

• Patients with serious trauma in the central nervous system,

• with bleeding probably requiring surgical hemostasis,

• drug overdose within the last 30 days before study entry,

• pregnancy/lactation,

• contraindication to alpha-2-adrenoceptor agonists or antagonists,

• cardiovascular disease,

• conduction disturbances or difficulty in data collection or completing the study protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trauma

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine sedation at a starting dose of 0.2-7.0 µg/kg/hour.
• Propofol
Propofol sedation at a starting dose of 10-70 µg/kg/hour.

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut	Assiut governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of time with in the target sedation range of Richmond Agitation Sedation Scale-3-0	sedation goal is to maintain Richmond Agitation Sedation Scale from -3 up to 0	3 days	No
Secondary	serum BUN	Assessment of the serum level of BUN.	3-days	Yes
Secondary	Serum creatinine.	Assessment of the serum level of creatinine.	3-days	Yes
Secondary	Systolic blood pressure	systolic blood pressure is measured every hour for 3- days.	3- days.	Yes
Secondary	diastolic blood pressure	diastolic blood pressure is measured every hour for 3- days.	3- days.	Yes
Secondary	heart rate	heart rate is recorded every hour for 3-days.	3- days.	Yes