This study will be conducted on aneurysmal subarachnoid hemorrhage patients.
Conditions
Interventions
Trade Name: The product to be used in the trial is dexmedetomidine, dexdor®, Orion Corporation.
Product Name: dexdor®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: D
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients with aneurysmal SAH after aneurysmal treatment (coiling or clipping) in the ICU of Turku University Hospital will be considered eligible for the study. 15 SAH patients requiring sedation and mechanical ventilation are enrolled in to the study. Inclusion criteria: 1. SAH due to ruptured aneurysm 2. Aneurysm treated with coils or clip(s). 3. Age 18-80 4. Written informed consent from the next of kin. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Preoperative 1. Pregnancy 2. Nursing woman 3. Sick sinus syndrome 4. Carotid stenosis (contraindication for dynamic autoregulation study) During dexmedetomidine infusion 1. Sinus arrest 2. Increased ICP refractory to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of this study is to investigate how dexmedetomidine affects static and dynamic autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal SAH patients. Dexmedetomidine (dexdor®) is a sedative agent, which got a centralised marketing authorisation from European Commission in September 2011. The static and dynamic autoregulation is first assessed during propofol infusion (before commencing dexmedetomidine infusion) and then during dexmedetomidine infusion. Autoregulation is assessed by means of transcranial doppler (TCD). During propofol infusion and dexmedetomidine infusion the ICP, brain oxygen saturation and brain tissue oxygen tension (PbrO2) (if applicable) are recorded as well. ;Secondary Objective: Please see main objective of the trial.;Primary end point(s): We are interested in whether dexmedetomidine affects the autoregulation of the brain in SAH patients or not. There will be no actual end points.;Timepoint(s) of evaluation of this end point: Please see E.5.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Please see E.5.1.;Timepoint(s) of evaluation of this end point: Please see E.5.1. | — |
Countries
Finland
Contacts
Public ContactDepartment of Anaesthesiology
Turku University Hospital
Outcome results
None listed