Dexmedetomidine and Subarachnoid Haemorrhage

Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01664520
• Other study ID #: Turku University Hospital
• Secondary ID: 2012-000068-11KL
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 4, 2012
• Last updated: February 3, 2017
• Start date: June 2013
• Est. completion date: December 30, 2016

Study information

• Verified date: February 2017
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2, 4 and 6 hours