Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Medical University of Gdansk
Sponsor:
Information provided by (Responsible Party):
Radoslaw Owczuk, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01714388
First received: October 23, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

Remifentanil (RMFNT) is a very short active opioid, used for analgesia during general anaesthesia and for analgosedation in intensive care units (ICU). Registration for anesthesia includes bolus dose and continuous infusion, in ICU only infusion regimen is allowed. PK/PD 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 parasympaticomimetic 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 HF power and HF/(LF+HF) ratio in frequency domain and RMSSD, NN50, 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 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
Autonomic Nervous Sytem Activity
Inluence of Remifentanil on Autonomic Nervous System
Drug: Remifentanil

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: up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Remifentanil, Vagotonic response 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients ASA I-II status
  • planned surgery under general anaesthesia

Exclusion Criteria:

  • known sensivity to remifentanil
  • anticipated problems with tracheal intubation
  • incresed risk of aspiration
  • diabetic patients
  • patients taking medications with known influence on autonomic nervous system
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714388

Locations
Poland
Medical University of Gdansk Recruiting
Gdansk, Poland, 80-211
Contact: Magdalena A. Wujtewicz, MD., PhD    48583493281    magwuj@gumed.edu.pl   
Sponsors and Collaborators
Medical University of Gdansk
  More Information

No publications provided

Responsible Party: Radoslaw Owczuk, associate 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: October 24, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Gdansk:
remifentanil
heart rate
autonomic nervous system
heart rate variability

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

ClinicalTrials.gov processed this record on November 25, 2014