Autonomic Nervous System Activity | Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.
Autonomic Nervous System Activity research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Autonomic Nervous System Activity
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Remifentanil1mcg/kg iv dose, followed by 5 minutes ECG recording
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Remifentanil, Vagotonic response1 microgram/kg remifentanil given iv over at least 30 sec. at the beginning of induction of general anaesthesia
Start Date: May 2010
Completed Date: March 2015
Phase: Phase 4
Primary Outcome: Vagomimetic effect of RMFNT in reference to autonomic nervous system activity
Study sponsors, principal investigator, and references
Principal Investigator: Magdalena Wujtewicz
Lead Sponsor: Medical University of Gdansk