Haemodynamic Effect of Dexmedetomidine
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedOctober 18, 2021
October 1, 2021
3.2 years
September 30, 2015
October 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of haemodynamics and heart rate variability parameters
up to 30 minutes
Study Arms (1)
Dexmedetomidine
EXPERIMENTALDexmedetomidine, 1 mcg/kg over 10 minutes, followed by a maintenance infusion, given to achieve sedation for eye surgery procedure
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients classified with American Society of Anesthesiologists Physical Status Classification System as 1 or 2 status
- planned eye surgery under sedation
You may not qualify if:
- patient's refusal
- contraindications to dexmedetomidine
- diseases/drugs that influence on autonomic nervous system activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Gdansk
Gdansk, 80-214, Poland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magdalena A Wujtewicz, M.D
Department of Ophthalmology, Medical University of Gdańsk
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 2, 2015
Study Start
June 1, 2015
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
October 18, 2021
Record last verified: 2021-10