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Completed

NCT Number: NCT02606409

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut university hospitals

Asyut, Assiut Governorate, 715715, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine sedation at a starting dose of 0.2-7.0 µg/kg/hour.

Other names: Precedex

Propofol

Drug

Propofol sedation at a starting dose of 10-70 µg/kg/hour.

Other names: Deprivan

Primary outcomes

  1. percentage of time with in the target sedation range of Richmond Agitation Sedation Scale-3-0

    Time frame: 3 days

    sedation goal is to maintain Richmond Agitation Sedation Scale from -3 up to 0

Secondary outcomes

  1. serum BUN

    Time frame: 3-days

    Assessment of the serum level of BUN.

  2. Serum creatinine.

    Time frame: 3-days

    Assessment of the serum level of creatinine.

  3. Systolic blood pressure

    Time frame: 3- days.

    systolic blood pressure is measured every hour for 3- days.

  4. diastolic blood pressure

    Time frame: 3- days.

    diastolic blood pressure is measured every hour for 3- days.

  5. heart rate

    Time frame: 3- days.

    heart rate is recorded every hour for 3-days.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: DEXsedation

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2015
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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