Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.

Autonomic Nervous System Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714388
• Other study ID #: GUMed-Ow-004
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2012
• Last updated: September 30, 2015
• Start date: May 2010
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Autonomic Nervous System Activity

Intervention

Drug:
• Remifentanil
1mcg/kg iv dose, followed by 5 minutes ECG recording

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vagomimetic effect of RMFNT in reference to autonomic nervous system activity		before and after drug injection	Yes