Dexmedetomidine and Subarachnoid Haemorrhage
|First Received Date ICMJE||August 4, 2012|
|Last Updated Date||August 30, 2013|
|Start Date ICMJE||June 2013|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change in autoregulation, ICP and cerebral oxygenation [ Time Frame: 2, 4 and 6 hours ] [ Designated as safety issue: Yes ]
Autoregulation is assessed using transcranial doppler (TCD) and ICP amplitude analysis. ICP and cerebral oxygenation are part of standard multimodal monitoring and these are continuously monitored and recorded.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01664520 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Dexmedetomidine and Subarachnoid Haemorrhage|
|Official Title ICMJE||The Effects of Dexmedetomidine on Cerebral Autoregulation and Cerebral Oxygenation in Subarachnoid Haemorrhage Patients|
The purpose of this study is to investigate how dexmedetomidine affects static and dynamic autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal subarachnoid haemorrhage (SAH) patients.
Dexmedetomidine is a selective α2-agonist which induces sedation, anxiolysis and analgesia without respiratory depression. These effects, as well as neuroprotective properties in experimental studies would be ideal in neuroanaesthesia and in neurocritical care. Poor grade SAH patients are treated in intensive care units (ICU). These patients are sedated often with propofol. However, to assess the patient's neurology, the propofol sedation must be stopped and the wakening of the patient may take time. Dexmedetomidine would be more advantageous, allowing wakening during the infusion. However, the effects of dexmedetomidine on cerebral autoregulation are unknown in SAH patients.
15 SAH patients requiring sedation, mechanical ventilation and ICP monitoring will be rolled in to the study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Intervention ICMJE||Drug: Dexmedetomidine infusion
Both static and dynamic autoregulation are assessed first during propofol infusion, before commencement of dexmedetomidine infusion. Dexmedetomidine infusion is commenced with a dose of 0.7 μg/kg/h and propofol infusion is stopped concomitantly. After 2 hours dexmedetomidine infusion, the static and dynamic autoregulation are assessed. If there are no signs of worsening of autoregulation, then the dexmedetomidine infusion is increased to 1 μg/kg/h and after 2 hours the static and dynamic autoregulation are assessed again. However, if autoregulation worsens during dexmedetomidine infusion, it will be stopped and further testing with dexmedetomidine will not be carried out. If autoregulation does not worsen with the 1 μg/kg/h dose then the dose will be increased to 1.4 μg/kg/h. After 2 hours infusion the dynamic and static autoregulation are assessed again.
Blood samples for determining dexmedetomidine plasma concentration are collected alongside with the autoregulation assessments
|Study Arm (s)||Experimental: Dexmedetomine infusion
Intervention: Drug: Dexmedetomidine infusion
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||15|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Finland|
|NCT Number ICMJE||NCT01664520|
|Other Study ID Numbers ICMJE||Turku University Hospital, 2012-000068-11, KLNRO 45/2012|
|Has Data Monitoring Committee||No|
|Responsible Party||Riikka Takala, Turku University Hospital|
|Study Sponsor ICMJE||Turku University Hospital|
|Collaborators ICMJE||Orion Corporation, Orion Pharma|
|Information Provided By||Turku University Hospital|
|Verification Date||June 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP