Vagotonic Effect of Remifentanil in Reference to Sympathetic or Parasympathetic Predominance of Autonomic Nervous System.
Overview
- Phase
- Phase 4
- Intervention
- Remifentanil
- Conditions
- Autonomic Nervous System Activity
- Sponsor
- Medical University of Gdansk
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Vagomimetic effect of RMFNT in reference to autonomic nervous system activity
- Status
- Completed
- Last Updated
- 10 years ago
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.
Investigators
Magdalena Wujtewicz
assistant professor
Medical University of Gdansk
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
Arms & Interventions
Remifentanil, Vagotonic response
1 microgram/kg remifentanil given iv over at least 30 sec. at the beginning of induction of general anaesthesia
Intervention: Remifentanil
Outcomes
Primary Outcomes
Vagomimetic effect of RMFNT in reference to autonomic nervous system activity
Time Frame: before and after drug injection