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Clinical Trials/NCT01714388
NCT01714388
Completed
Phase 4

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

Medical University of Gdansk1 site in 1 country70 target enrollmentMay 2010

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
March 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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