Pain
Conditions
Keywords
pain assessment, anesthesia, analgesia, opioid, HRV, APV, autonomic nervous system (ANS), pupil size
Brief summary
During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid treatment is used for pain assessment. The change in haemodynamic variables and clinical sign are evaluated during anesthesia for pain assessment but these changes are not specific every time. The main of this study is to investigate the relationship between calculated compartment concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability) and APV (Arterial Pressure Variability) before a standard noxious stimulation during general anesthesia at calibrated hypnosis level. Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and that these effects would be blunted or abolished by by adequate analgesia. The current study is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during nociceptive surgical stimulation, at different levels of analgesia.
Interventions
DRUGopioid (remifentanyl)
Infusion of remifentanyl (opioid) will be started at different levels for each group of the randomized study : 0 ng/ml (group 0), 1 ng/ml (group 1), 3 ng/ml (group 3) or 4 ng/ml (group 4)
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients under 55 years-old * ASA status 1 or 2 * scheduled to undergo general anesthesia for different types of surgery (neurosurgical or medullar surgery, ear, nose or throat surgery or orthopedic surgery)
Exclusion criteria
* history of cardiac or autonomic disease * diabetes * obesity (BMI\>30 kg/m2) * medication altering autonomic nervous system tone * history of eyes surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HRV measurements during noxious stimulation | baseline and 5 minutes | Analyse of HRV is a widely used, non-invasive technique to assess autonomic nervous system (ANS) activity. The typical spectral pattern of HRV includes two main spectral peaks : a low-freqency (LF) region, affected by both sympathetic and parasympathic activity, and a high-frequency (HF) peak centered at the respiratory frequency, which is associated with parasympathetic activity. |
| change from baseline in APV measurements during noxious stimulation | baseline and 5 minutes | Analyse of APV is a widely used, non-invasive technique to assess autonomic nervous system (ANS) activity. The typical spectral pattern of APV includes two main spectral peaks : a low-freqency (LF) region, affected by both sympathetic and parasympathic activity, and a high-frequency (HF) peak centered at the arterial pressure, which is associated with parasympathetic activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in BIS (Bispectral Index) during noxious stimulation | baseline and 5 minutes | bispectral index will be recorded before induction of anesthesia, just before nociceptive stimulation, then every 30 seconds up to the end of the five minutes after nociceptive stimulation. BIS will be used to estimate pain |
| Change from baseline in pupil change during noxious stimulation | baseline and 5 minutes | pupil size will be monitored and recored using an infrared pupilometry system consisting of a camera, infrared lignt source, video monitor and video processing software, capturing pupil diameter as a real-time analogue signal (rate of 25 Hz). The pupil size variability will be used to estimate pain |
| Change from baseline in diastolic blood pressure during noxious stimulation | basline and 5 minutes | diastolic blood pressure will be recorded before induction of anesthesia, just before nociceptive stimulation, then every 30 seconds up to the end of the five minutes after nociceptive stimulation. diastolic blood pressure will be used to estimate pain |
| change from baseline in systolic blood pressure during noxious baseline | baseline and 5 minutes | Systolic blood pressure will be recorded before induction of anesthesia, just before nociceptive stimulation, then every 30 seconds up to the end of the five minutes after nociceptive stimulation. Systolic blood pressure measurement will be used to estimate pain |
| change from baseline in heart rate during noxious stimulation | baseline and 5 minutes | heart rate will be recorded before induction of anesthesia, just before nociceptive stimulation, then every 30 seconds up to the end of the five minutes after nociceptive stimulation. The heart rate measurement will be used to estimate pain. |
Countries
France
Outcome results
None listed