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OpenTrials
Completed

NCT Number: NCT02566863

Haemodynamic Effect of Dexmedetomidine

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.

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Key information

Conditions

Haemodynamic Effects of Dexmedetomidine

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Gdansk

Gdansk, 80-214, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Primary outcomes

  1. Changes of haemodynamics and heart rate variability parameters

    Time frame: up to 30 minutes

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

Haemodynamic Effect of Dexmedetomidine in Relation to Autonomic System Activity

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 2, 2015
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.