Dexmedetomidine and Subarachnoid Haemorrhage

Phase 1

Completed

• Conditions: Subarachnoid Hemorrhage; Aneurysm
• Interventions: Drug: Dexmedetomidine infusion

• Registration Number: NCT01664520
• Lead Sponsor: Turku University Hospital

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.

Study Timeline

• Study First Submitted: 2012-08-04
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-14
• Study Start: 2013-06
• Primary Completion: 2016-11-30
• Study Completion: 2016-12-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexmedetomine infusion	Dexmedetomidine infusion	-

Primary Outcome Measures

Name	Time	Method
Change in autoregulation, ICP and cerebral oxygenation	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.

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland