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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
  Purpose
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.

Condition Intervention Phase
Subarachnoid Hemorrhage Aneurysm Drug: Dexmedetomidine infusion Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Dexmedetomidine on Cerebral Autoregulation and Cerebral Oxygenation in Subarachnoid Haemorrhage Patients

Resource links provided by NLM:


Further study details as provided by Riikka Takala, Turku University Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: June 2013
Study Completion Date: December 30, 2016
Primary Completion Date: November 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomine infusion 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


Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664520


Locations
Finland
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Orion Corporation, Orion Pharma
Investigators
Study Director: Riikka SK Takala, MD PhD Turku University Hospital
  More Information

Responsible Party: Riikka Takala, MD, PhD Senior Staff Anaesthesiologist, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01664520     History of Changes
Other Study ID Numbers: Turku University Hospital
2012-000068-11 ( EudraCT Number )
KLNRO 45/2012 ( Other Identifier: Finnish Medicines Agency )
First Submitted: August 4, 2012
First Posted: August 14, 2012
Last Update Posted: February 6, 2017
Last Verified: February 2017

Keywords provided by Riikka Takala, Turku University Hospital:
Subarachnoid hemorrhage
Dexmedetomidine
Autoregulation
Intracranial pressure
Cerebral oxygenation

Additional relevant MeSH terms:
Hemorrhage
Aneurysm
Subarachnoid Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action