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Completed

NCT Number: NCT01664520

Dexmedetomidine and Subarachnoid Haemorrhage

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.

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Key information

Conditions

Subarachnoid Hemorrhage Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Turku University Hospital

Turku, 20520, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine infusion

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Orion Corporation, Orion Pharma

Registry information

Official study title

The Effects of Dexmedetomidine on Cerebral Autoregulation and Cerebral Oxygenation in Subarachnoid Haemorrhage Patients

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2012
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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