Dexmedetomidine and Subarachnoid Haemorrhage

NCT01664520 | Completed Phase 1

• 3 other identifiers: Turku University Hospital2012-000068-11KLNRO 45/2012
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage; Aneurysm

Keywords

Subarachnoid hemorrhage; Dexmedetomidine; Autoregulation; Intracranial pressure; Cerebral oxygenation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Dexmedetomine infusion

EXPERIMENTAL

Drug: Dexmedetomidine infusion

Interventions

Dexmedetomidine infusion 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

Dexmedetomine infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aneurysmal SAH
• Aneurysm treated with coil(s) or clip(s)
• Age 18-80 years
• Written informed consent from the next of kin

You may not qualify if:

• Pregnancy
• Nursing woman
• Sick sinus syndrome
• Carotid stenosis
• Heart rate less than 50 beats / minute
• Mean arterial pressure less than 50 mmHg

Sponsors & Collaborators

• Turku University Hospital: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Riikka SK Takala, MD PhD

  Turku University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Senior Staff Anaesthesiologist

Study Record Dates

• First Submitted: August 4, 2012
• First Posted: August 14, 2012
• Study Start: June 1, 2013
• Primary Completion: November 30, 2016
• Study Completion: December 30, 2016
• Last Updated: February 6, 2017

Record last verified: 2017-02

Locations

FI (1)