We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dexmedetomidine and Subarachnoid Haemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01664520
First Posted: August 14, 2012
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Riikka Takala, Turku University Hospital
August 4, 2012
August 14, 2012
February 6, 2017
June 2013
November 30, 2016   (Final data collection date for primary outcome measure)
Change in autoregulation, ICP and cerebral oxygenation [ Time Frame: 2, 4 and 6 hours ]
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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Single Group Assignment
Masking: None (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 30, 2016
November 30, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01664520
Turku University Hospital
2012-000068-11 ( EudraCT Number )
KLNRO 45/2012 ( Other Identifier: Finnish Medicines Agency )
No
Not Provided
Not Provided
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
February 2017

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