Completed

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

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What is being tested

Dexmedetomidine infusion

Drug
Who is being recruted

Brain Diseases+9

+ Cardiovascular Diseases

+ Central Nervous System Diseases

From 18 to 80 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1 & 2
Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorTurku University Hospital
Last updated: February 6, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01664520
Principal SponsorTurku University Hospital
Last updated: February 6, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersHemorrhageNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesIntracranial HemorrhagesAneurysmSubarachnoid Hemorrhage

Criteria

4 inclusion criteria required to participate
Age 18-80 years
Aneurysm treated with coil(s) or clip(s)
Aneurysmal SAH
Written informed consent from the next of kin
6 exclusion criteria prevent from participating
Carotid stenosis
Heart rate less than 50 beats / minute
Mean arterial pressure less than 50 mmHg
Nursing woman
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Turku University Hospital

Turku, FinlandOpen Turku University Hospital in Google Maps
CompletedOne Study Center