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

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.

Study Overview

• Status: Completed
• Conditions: Trauma
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Propofol

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut governorate
    • Assiut, Assiut governorate, Egypt, 715715
      • Assiut university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine; Dexmedetomidine intravenous sedation at 0.2-0.7 µg/kg/h for >24h.	Drug: Dexmedetomidine; Dexmedetomidine sedation at a starting dose of 0.2-7.0 µg/kg/hour.; Other Names: Precedex
Active Comparator: Propofol; Propofol sedation at 10-70µg/kg/h for >24h.	Drug: Propofol; Propofol sedation at a starting dose of 10-70 µg/kg/hour.; Other Names: Deprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum BUN	Assessment of the serum level of BUN.	3-days
Serum creatinine.	Assessment of the serum level of creatinine.	3-days
Systolic blood pressure	systolic blood pressure is measured every hour for 3- days.	3- days.
diastolic blood pressure	diastolic blood pressure is measured every hour for 3- days.	3- days.
heart rate	heart rate is recorded every hour for 3-days.	3- days.

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 14, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Estimate): August 23, 2016
• Last Update Submitted That Met QC Criteria: August 20, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: IRB00008718/1548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No