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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


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


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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