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Haemodynamic Effect of Dexmedetomidine

Sponsor
Medical University of Gdansk (Other)
Overall Status
Completed
CT.gov ID
NCT02566863
Collaborator
(none)
64
Enrollment
1
Location
1
Arm
38
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart rate decreases. With low doses blood pressure also decreases, with higher dosing - systematic vascular resistance increases. The indication for the drug is to produce sedation during surgical procedures and in ICU patients.

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Haemodynamic Effect of Dexmedetomidine in Relation to Autonomic System Activity
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexmedetomidine

Dexmedetomidine, 1 mcg/kg over 10 minutes, followed by a maintenance infusion, given to achieve sedation for eye surgery procedure

Drug: 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 Names:
  • Dexdor
  • Precedex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes of haemodynamics and heart rate variability parameters [up to 30 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients classified with American Society of Anesthesiologists Physical Status Classification System as 1 or 2 status

    • planned eye surgery under sedation

    Exclusion Criteria:

    • patient's refusal

    • contraindications to dexmedetomidine

    • diseases/drugs that influence on autonomic nervous system activity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Gdansk Gdansk Poland 80-214

    Sponsors and Collaborators

    • Medical University of Gdansk

    Investigators

    • Principal Investigator: Magdalena A Wujtewicz, M.D, Department of Ophthalmology, Medical University of Gdańsk

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Magdalena Wujtewicz, M.D., Ph.D, Medical University of Gdansk
    ClinicalTrials.gov Identifier:
    NCT02566863
    Other Study ID Numbers:
    • GUMed-Wu-003
    First Posted:
    Oct 2, 2015
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by Magdalena Wujtewicz, M.D., Ph.D, Medical University of Gdansk
    dexmedetomidine
    heart rate
    heart rate variability
    Additional relevant MeSH terms:
    Dexmedetomidine

    Study Results

    No Results Posted as of Oct 18, 2021