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Completed

NCT Number: NCT01303471

Pain Assessment During General Anesthesia

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

opioid (remifentanyl)

Drug

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)

Primary outcomes

  1. Change from baseline in HRV measurements during noxious stimulation

    Time frame: 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.

  2. change from baseline in APV measurements during noxious stimulation

    Time frame: 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 outcomes

  1. Change from baseline in pupil change during noxious stimulation

    Time frame: 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

  2. change from baseline in heart rate during noxious stimulation

    Time frame: 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.

  3. Change from baseline in BIS (Bispectral Index) during noxious stimulation

    Time frame: 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

  4. change from baseline in systolic blood pressure during noxious baseline

    Time frame: 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

  5. Change from baseline in diastolic blood pressure during noxious stimulation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Pain Assessment During General Anesthesia : DOLANS (DOULeur ANeSthesie) Study

Acronym: DOLANS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 24, 2011
Registry last updated
May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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