Haemodynamic Effect of Dexmedetomidine

Haemodynamic Effect of Dexmedetomidine in Relation to Autonomic System Activity

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02566863

Enrollment

Registered

2015-10-02

Start date

2015-06-30

Completion date

2018-08-31

Last updated

2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemodynamic Effects of Dexmedetomidine

Keywords

dexmedetomidine, heart rate, heart rate variability

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.

Interventions

DRUGDexmedetomidine

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes of haemodynamics and heart rate variability parameters	up to 30 minutes

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026