Dexmedetomidine and Subarachnoid Haemorrhage

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Turku University Hospital
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Riikka Takala, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01664520
First received: August 4, 2012
Last updated: August 30, 2013
Last verified: June 2013

August 4, 2012
August 30, 2013
June 2013
Not Provided
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.
Same as current
Complete list of historical versions of study NCT01664520 on ClinicalTrials.gov Archive Site
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Dexmedetomidine and Subarachnoid Haemorrhage
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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Subarachnoid Hemorrhage
  • Aneurysm
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

Experimental: Dexmedetomine infusion
Intervention: Drug: Dexmedetomidine infusion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
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Inclusion Criteria:

  • Aneurysmal SAH
  • Aneurysm treated with coil(s) or clip(s)
  • Age 18-80 years
  • Written informed consent from the next of kin

Exclusion Criteria:

  • Pregnancy
  • Nursing woman
  • Sick sinus syndrome
  • Carotid stenosis
  • Heart rate less than 50 beats / minute
  • Mean arterial pressure less than 50 mmHg
Both
18 Years to 80 Years
No
Contact: Riikka SK Takala, MD PhD +358405130441 riikka.takala@gmail.com
Contact: Minna Kallioinen, MD minna.kallioinen@tyks.fi
Finland
 
NCT01664520
Turku University Hospital, 2012-000068-11, KLNRO 45/2012
No
Riikka Takala, Turku University Hospital
Turku University Hospital
Orion Corporation, Orion Pharma
Study Director: Riikka SK Takala, MD PhD Turku University Hospital
Turku University Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP