Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.

Study Overview
=================
Brief Summary
-----------------
Remifentanil (RMFNT) is a very short active opioid, used for analgesia during general anaesthesia and for analgesic and sedative effect in intensive care units (ICU) patients. Registration for anesthesia includes bolus dose and continuous infusion, in ICU only infusion regimen is allowed. Pharmacokinetic/pharmacodynamic 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 parasympathomimetic 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 high frequency (HF) power and HF/(LF+HF) (LF-low frequency) ratio in frequency domain and Root Mean Square of the Successive Difference (RMSSD), the number of pairs of successive NNs that differ by more than 50 ms (NN50), the proportion of NN50 divided by total number of NNs (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 electrocardiogram (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.

Official Title
-----------------
Vagotonic Effect of Remifentanil in Reference to Sympathetic or Parasympathetic Predominance of Autonomic Nervous System.

Conditions
-----------------
Autonomic Nervous System Activity

Intervention / Treatment
-----------------
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients assessed with American Society of Anesthesiologists' Physical Status Classification System as 1-2 status planned surgery under general anaesthesia Exclusion Criteria: known sensitivity to remifentanil anticipated problems with tracheal intubation increased risk of aspiration diabetic patients patients taking medications with known influence on autonomic nervous system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanil, Vagotonic response<br>1 microgram/kg remifentanil given iv over at least 30 sec. at the beginning of induction of general anaesthesia | Drug: Remifentanil<br>* 1mcg/kg iv dose, followed by 5 minutes ECG recording<br>* Other names: Ultiva;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vagomimetic effect of RMFNT in reference to autonomic nervous system activity |  | before and after drug injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remifentanil, heart rate, autonomic nervous system, heart rate variability, autonomic nervous activity, vagotonic effect, single dose