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Haemodynamic Effect of Dexmedetomidine

NCT02566863 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-10-18

No results posted yet for this study

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.

Conditions

  • Haemodynamic Effects of Dexmedetomidine

Interventions

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.

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Principal Investigators

  • Magdalena A Wujtewicz, M.D · Department of Ophthalmology, Medical University of Gdańsk

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02566863 on ClinicalTrials.gov