Heart Rate Variability and Postoperative Pain (ECG-Spectral)
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|ClinicalTrials.gov Identifier: NCT00438035|
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : August 12, 2008
|Condition or disease||Intervention/treatment||Phase|
|Pain Postoperative||Procedure: ECG spectral||Not Applicable|
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Postoperative Pain by Spectral Analysis of ECG R-R Intervals|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
- Spectral ECG [ Time Frame: Preoperative and postoperative time ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438035
|Service de Neurochirurgie A, hôpital Pellegrin|
|Bordeaux Cedex, Place Amélie Raba-Léon, France, 33076|
|Principal Investigator:||Musa SESAY, MD||University Hospital, Bordeaux|