NCT02566863

Haemodynamic Effect of Dexmedetomidine

Haemodynamic Effect of Dexmedetomidine in Relation to Autonomic System Activity

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2015-10-02
• Last updated: 2021-10-18

Locations

1 site across 1 country: Poland