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Dexmedetomidine and Subarachnoid Haemorrhage

Primary Purpose

Subarachnoid Hemorrhage, Aneurysm

Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Dexmedetomidine infusion
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Subarachnoid Hemorrhage focused on measuring Subarachnoid hemorrhage, Dexmedetomidine, Autoregulation, Intracranial pressure, Cerebral oxygenation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dexmedetomine infusion

Arm Description

Outcomes

Primary Outcome Measures

Change in autoregulation, ICP and cerebral oxygenation
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.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2012
Last Updated
February 3, 2017
Sponsor
Turku University Hospital
Collaborators
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01664520
Brief Title
Dexmedetomidine and Subarachnoid Haemorrhage
Official Title
The Effects of Dexmedetomidine on Cerebral Autoregulation and Cerebral Oxygenation in Subarachnoid Haemorrhage Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysm
Keywords
Subarachnoid hemorrhage, Dexmedetomidine, Autoregulation, Intracranial pressure, Cerebral oxygenation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomine infusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine infusion
Intervention Description
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 Outcome Measure Information:
Title
Change in autoregulation, ICP and cerebral oxygenation
Description
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.
Time Frame
2, 4 and 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riikka SK Takala, MD PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland

12. IPD Sharing Statement

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Dexmedetomidine and Subarachnoid Haemorrhage

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