Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.

NCT ID: NCT01714388

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Remifentanil, Vagotonic response

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

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

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

Interventions

Remifentanil

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

Intervention Type: DRUG

Other Intervention Names

Ultiva

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Magdalena Wujtewicz

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magdalena Wujtewicz

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Medical University of Gdańsk

Locations

Medical University of Gdansk

Gdansk, , Poland

Countries

Poland

Other Identifiers

GUMed-Ow-004

Identifier Type: -

Identifier Source: org_study_id