Dexmedetomidine and Subarachnoid Haemorrhage
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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: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | The Effects of Dexmedetomidine on Cerebral Autoregulation and Cerebral Oxygenation in Subarachnoid Haemorrhage Patients |
- 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.
| Estimated Enrollment: | 15 |
| 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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Riikka SK Takala, MD PhD | +358405130441 | riikka.takala@gmail.com |
| Contact: Minna Kallioinen, MD | minna.kallioinen@tyks.fi |
| Finland | |
| Turku University Hospital | Not yet recruiting |
| Turku, Finland, 20520 | |
| Contact: Riikka SK Takala, MD PhD riikka.takala@gmail.com | |
| Principal Investigator: Minna Kallioinen, MD | |
| Principal Investigator: Ari J Katila, MD | |
| Study Director: | Riikka SK Takala, MD PhD | Turku University Hospital |
More Information
No publications provided
| 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, KLNRO 45/2012 |
| Study First Received: | August 4, 2012 |
| Last Updated: | August 9, 2012 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by Turku University Hospital:
|
Subarachnoid hemorrhage Dexmedetomidine Autoregulation Intracranial pressure Cerebral oxygenation |
Additional relevant MeSH terms:
|
Aneurysm Hemorrhage Subarachnoid Hemorrhage Vascular Diseases Cardiovascular Diseases Pathologic Processes 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 Pharmacologic Actions Central Nervous System Agents Therapeutic Uses 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 |
ClinicalTrials.gov processed this record on May 23, 2013