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Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Magdalena Wujtewicz, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01714388
First received: October 23, 2012
Last updated: September 30, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Autonomic Nervous System Activity
Drug: Remifentanil
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Vagotonic Effect of Remifentanil in Reference to Sympathetic or Parasympathetic Predominance of Autonomic Nervous System.

Resource links provided by NLM:


Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • Vagomimetic effect of RMFNT in reference to autonomic nervous system activity [ Time Frame: before and after drug injection ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: May 2010
Study Completion Date: March 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remifentanil, Vagotonic response
1 microgram/kg remifentanil given iv over at least 30 sec. at the beginning of induction of general anaesthesia
Drug: Remifentanil
1mcg/kg iv dose, followed by 5 minutes ECG recording
Other Name: Ultiva

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01714388

Locations
Poland
Medical University of Gdansk
Gdansk, Poland, 80-211
Sponsors and Collaborators
Medical University of Gdansk
Investigators
Principal Investigator: Magdalena Wujtewicz Department of Ophthalmology, Medical University of Gdańsk
  More Information

Responsible Party: Magdalena Wujtewicz, assistant professor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01714388     History of Changes
Other Study ID Numbers: GUMed-Ow-004 
Study First Received: October 23, 2012
Last Updated: September 30, 2015
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Gdansk:
remifentanil
heart rate
autonomic nervous system
heart rate variability
autonomic nervous activity
vagotonic effect
single dose

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 30, 2016