Dexmedetomidine and Subarachnoid Haemorrhage

NCT ID: NCT01664520

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-12-30

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.

Conditions

Subarachnoid Hemorrhage; Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dexmedetomine infusion

Group Type: EXPERIMENTAL

Dexmedetomidine infusion

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Riikka Takala

MD, PhD Senior Staff Anaesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Riikka SK Takala, MD PhD

Role: STUDY_DIRECTOR

Turku University Hospital

Locations

Turku University Hospital

Turku, , Finland

Countries

Finland

Other Identifiers

2012-000068-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KLNRO 45/2012

Identifier Type: OTHER

Identifier Source: secondary_id

Turku University Hospital

Identifier Type: -

Identifier Source: org_study_id