Heart Rate Variability and Postoperative Pain
ECG-Spectral
Evaluation of Postoperative Pain by Spectral Analysis of ECG R-R Intervals
1 other identifier
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Feb 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 19, 2007
CompletedFirst Posted
Study publicly available on registry
February 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedAugust 12, 2008
February 1, 2007
1 year
February 19, 2007
August 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spectral ECG
Preoperative and postoperative time
Interventions
Eligibility Criteria
You may qualify if:
- Patients over 18 years old scheduled for surgery under general anesthesia.
- Patient able to use the visual analog pain scale
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Neurochirurgie A, hôpital Pellegrin
Bordeaux, Place Amélie Raba-Léon, 33076, France
Related Publications (2)
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. doi: 10.1007/BF03016878. French.
PMID: 12419720BACKGROUNDSesay M, Robin G, Tauzin-Fin P, Sacko O, Gimbert E, Vignes JR, Liguoro D, Nouette-Gaulain K. Responses of heart rate variability to acute pain after minor spinal surgery: optimal thresholds and correlation with the numeric rating scale. J Neurosurg Anesthesiol. 2015 Apr;27(2):148-54. doi: 10.1097/ANA.0000000000000102.
PMID: 25105826DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Musa SESAY, MD
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 19, 2007
First Posted
February 21, 2007
Study Start
February 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
August 12, 2008
Record last verified: 2007-02