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

NCT ID: NCT02606409

Last Updated: 2016-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-06-30

Brief 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.

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.

Conditions

Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine

Dexmedetomidine intravenous sedation at 0.2-0.7 µg/kg/h for \>24h.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

Propofol

Propofol sedation at 10-70µg/kg/h for \>24h.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

Propofol

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

Intervention Type: DRUG

Other Intervention Names

Precedex; Deprivan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt

Locations

Assiut university hospitals

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB00008718/1548

Identifier Type: -

Identifier Source: org_study_id