Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.
Information source: Medical University of Gdansk
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autonomic Nervous Sytem Activity
Intervention: Remifentanil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Medical University of Gdansk
Summary
Remifentanil (RMFNT) is a very short active opioid, used for analgesia during general
anaesthesia and for analgosedation in intensive care units (ICU). Registration for
anesthesia includes bolus dose and continuous infusion, in ICU only infusion regimen is
allowed. PK/PD parameters of RMFNT results in rapid onset and offset of clinical effect,
which makes this drug almost ideal in many situations. Unfortunately, its vagomimetic
influence on cardiac activity may result in decrease of heart rate. It may be hypothesized
that patients with parasympathetic predominance may be prone to more intense
parasympaticomimetic effect of this opioid. An optimal method for assessment of autonomic
nervous system activity and assessment of influence of RMFNT on that activity is Heart Rate
Variability (HRV) analysis. Parasympathetic predominance is expressed as HF power and
HF/(LF+HF) ratio in frequency domain and RMSSD, NN50, pNN50 in time domain. The aim of this
study is to verify the hypothesis that patients with predominance of parasympathetic
activity are more subject to vagomimetic effect of RMFNT. HRV based on 5 minutes ECG
recorded before and after bolus dose of RMFNT will be analyzed. The occurrence of heart rate
decrease will be than compared between patients with sympathetic and parasympathetic
predominance measured prior to drug injection.
Clinical Details
Official title: Vagotonic Effect of Remifentanil in Reference to Sympathetic or Parasympathetic Predominance of Autonomic Nervous System.
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Vagomimetic effect of RMFNT in reference to autonomic nervous system activity
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients ASA I-II status
- planned surgery under general anaesthesia
Exclusion Criteria:
- known sensivity to remifentanil
- anticipated problems with tracheal intubation
- incresed risk of aspiration
- diabetic patients
- patients taking medications with known influence on autonomic nervous system
Locations and Contacts
Medical University of Gdansk, Gdansk 80-211, Poland
Additional Information
Starting date: May 2010
Last updated: August 3, 2015
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