Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.

NCT01714388 | Completed Phase 4

• 1 other identifier: GUMed-Ow-004
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Nervous System Activity

Keywords

remifentanil; heart rate; autonomic nervous system; heart rate variability; autonomic nervous activity; vagotonic effect; single dose

Outcome Measures

Primary Outcomes (1)

• Vagomimetic effect of RMFNT in reference to autonomic nervous system activity

  before and after drug injection

Study Arms (1)

Remifentanil, Vagotonic response

EXPERIMENTAL

1 microgram/kg remifentanil given iv over at least 30 sec. at the beginning of induction of general anaesthesia

Drug: Remifentanil

Interventions

Remifentanil DRUG

1mcg/kg iv dose, followed by 5 minutes ECG recording

Also known as: Ultiva

Remifentanil, Vagotonic response

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients assessed with American Society of Anesthesiologists' Physical Status Classification System as 1-2 status
• planned surgery under general anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Magdalena Wujtewicz

  Department of Ophthalmology, Medical University of Gdańsk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 25, 2012
• Study Start: May 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

PL (1)