Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01714388
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : October 2, 2015
Information provided by (Responsible Party):
Magdalena Wujtewicz, Medical University of Gdansk

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.

Condition or disease Intervention/treatment Phase
Autonomic Nervous System Activity Drug: Remifentanil Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Vagotonic Effect of Remifentanil in Reference to Sympathetic or Parasympathetic Predominance of Autonomic Nervous System.
Study Start Date : May 2010
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Vagomimetic effect of RMFNT in reference to autonomic nervous system activity [ Time Frame: before and after drug injection ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01714388

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

Responsible Party: Magdalena Wujtewicz, assistant professor, Medical University of Gdansk Identifier: NCT01714388     History of Changes
Other Study ID Numbers: GUMed-Ow-004
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015

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

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