Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
64 participants
INTERVENTIONAL
2015-06-30
2018-08-31
Brief Summary
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The aim of a study is to verify, whether the haemodynamic effect (heart rate, blood pressure and heart rate variability during drug infusion) depend on pre-drug autonomic system activity. Autonomic system activity is assessed using heart rate variability (HRV)measurement before drug injection and during drug infusion. Heart rate and blood pressure measured before and during drug infusion will be analysed.
HRV measurement analysis will be based on continuous Holter ECG recording, taken before drug injection and during its infusion. 5 minutes intervals will be analysed , using Frequency Domain Measures of HRV. Surgical procedure will start after measurement have been taken.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Dexmedetomidine
Dexmedetomidine, 1 mcg/kg over 10 minutes, followed by a maintenance infusion, given to achieve sedation for eye surgery procedure
Dexmedetomidine
1 mcg/kg over 10 minutes, followed by a maintenance infusion titrated to achieve desired clinical effect - Richmond Agitation Scale between 0 and (-) 3. Holter ECG recording before start of infusion and during infusion for 25 minutes.
Interventions
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Dexmedetomidine
1 mcg/kg over 10 minutes, followed by a maintenance infusion titrated to achieve desired clinical effect - Richmond Agitation Scale between 0 and (-) 3. Holter ECG recording before start of infusion and during infusion for 25 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* planned eye surgery under sedation
Exclusion Criteria
* contraindications to dexmedetomidine
* diseases/drugs that influence on autonomic nervous system activity
20 Years
65 Years
ALL
No
Sponsors
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Medical University of Gdansk
OTHER
Responsible Party
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Magdalena Wujtewicz
M.D., Ph.D
Principal Investigators
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Magdalena A Wujtewicz, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Medical University of Gdańsk
Locations
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Medical University of Gdansk
Gdansk, , Poland
Countries
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Other Identifiers
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GUMed-Wu-003
Identifier Type: -
Identifier Source: org_study_id