Haemodynamic Effect of Dexmedetomidine

Phase 4

Completed

• Conditions: Haemodynamic Effects of Dexmedetomidine
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT02566863
• Lead Sponsor: Medical University of Gdansk

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-09
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• patients classified with American Society of Anesthesiologists Physical Status Classification System as 1 or 2 status
• planned eye surgery under sedation

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Exclusion Criteria

• patient's refusal
• contraindications to dexmedetomidine
• diseases/drugs that influence on autonomic nervous system activity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes of haemodynamics and heart rate variability parameters	up to 30 minutes

Trial Locations

Locations (1)

Medical University of Gdansk; 🇵🇱 Gdansk, Poland