Heart Rate Variability and Postoperative Pain (ECG-Spectral)

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT00438035

First received: February 19, 2007

Last updated: August 11, 2008

Last verified: February 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

February 19, 2007

Last Updated Date

August 11, 2008

Start Date ^ICMJE

February 2007

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Spectral ECG [ Time Frame: Preoperative and postoperative time ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00438035 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Heart Rate Variability and Postoperative Pain

Official Title ^ICMJE

Evaluation of Postoperative Pain by Spectral Analysis of ECG R-R Intervals

Brief Summary

Postoperative pain stimulates the autonomic nervous system, induces the production of pro-inflammatory substances, reduces patient mobility and impairs vital functions. The ECG spectral analysis (ECGs) is a non-invasive marker of the autonomic nervous system state. To our knowledge, the correlation between the sympathovagal activity quantified by a non invasive method and the postoperative pain, has not been studied before.

Detailed Description

Principal Objective : 1)To quantify postoperative pain by the ECGs technique. 2) To compare the ECGs parameters with the visual analog pain scale (VAS) results.
Secondary Objective : To determine the influence of preoperative chronic pain and pathophysiological profiles on the correlation between postoperative ECGs and VAS.
Study design : An observational, prospective, single arm, single center study.
Inclusion criteria : ¨Patients over 18 years old scheduled for surgery under general anesthesia. Patients capable of using the visual analog pain scale.
Exclusion criteria : Pregnancy or breast feeding, impossibility to obtain an informed consent, incapacity to follow all the study schedule. Patient not protected by social security, patient likely to present hypovolemia or severe hemodynamic instability. Patient with a dysautonomia characterized by orthostatic hypotension, patients with cardiac disarrhythmias, likely to interfere with the ECG and/or the spectral analysis of ECG.
Study plan: Patients will sign their informed consent during the V0 visit (preoperative). During V0, HF and LF (ECGs parameters) will be measured as well as the VAS-estimated pain. These results, medical history, concomitant diseases and medications will be reported in a case report form (CRF). The second and last visit, V1, takes place 1 hour after the patient wakes up, in the postoperative period. ECGs and VAS evaluation will be achieved in the same manner as the V0 visit. The only difference is that the measurements will be repeated to obtain a total of 5 data couples over 2 hours. These Intrapatient estimations will be used to improve statistical ECGs vs VAS correlation analysis.
Number of subjects : 100

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Pain
Postoperative

Intervention ^ICMJE

Procedure: ECG spectral

Study Arm (s)

Not Provided

Publications *

Sesay M, Vignes JR, Liguoro D, Crozat P, Boulard G, Guerin J, Barat M, Maurette P. [Autonomic hyperreflexia induced by sacral root stimulation is detected by spectral analysis of the EEG] Can J Anaesth. 2002 Nov;49(9):936-41. French.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

106

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients over 18 years old scheduled for surgery under general anesthesia.
Patient able to use the visual analog pain scale

Exclusion Criteria:

Pregnancy or breast feeding
Impossibility to obtain an informed consent
Incapacity to follow all the study schedule
Patient not protected by social security
Patient likely to present hypovolemia or severe hemodynamic instability
Patient with a dysautonomia characterized by orthostatic hypotension
Patient with cardiac disarrhythmias, likely to interfere with the ECG and/or the spectral analysis of ECG

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00438035

Other Study ID Numbers ^ICMJE

AOI 2002

Has Data Monitoring Committee

Responsible Party

Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux

Study Sponsor ^ICMJE

University Hospital, Bordeaux

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Musa SESAY, MD

University Hospital, Bordeaux

Information Provided By

University Hospital, Bordeaux

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top