Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.

September 30, 2015 updated by: Magdalena Wujtewicz, Medical University of Gdansk

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vagomimetic effect of RMFNT in reference to autonomic nervous system activity
Time Frame: before and after drug injection
before and after drug injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

  • Principal Investigator: Magdalena Wujtewicz, Department of Ophthalmology, Medical University of Gdańsk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUMed-Ow-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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