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Pain Assessment During General Anesthesia (DOLANS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01303471
First received: February 18, 2011
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Pain
 Drug: opioid (remifentanyl)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
Official Title: Pain Assessment During General Anesthesia : DOLANS (DOULeur ANeSthesie) Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Change from baseline in HRV measurements during noxious stimulation [ Time Frame: baseline and 5 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 5 minutes ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change from baseline in pupil change during noxious stimulation [ Time Frame: baseline and 5 minutes ] [ Designated as safety issue: No ]
    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 heart rate during noxious stimulation [ Time Frame: baseline and 5 minutes ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in BIS (Bispectral Index) during noxious stimulation [ Time Frame: baseline and 5 minutes ] [ Designated as safety issue: No ]
    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 systolic blood pressure during noxious baseline [ Time Frame: baseline and 5 minutes ] [ Designated as safety issue: No ]
    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 diastolic blood pressure during noxious stimulation [ Time Frame: basline and 5 minutes ] [ Designated as safety issue: No ]
    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


Enrollment: 75
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: opioïd
Different levels of remifentanyl of each group during nociceptive stimulation
 Drug: opioid (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)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303471

Locations
France
CHU de Saint-Etienne
Saint-Etienne, France, 42100
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: David Charier CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01303471     History of Changes
Other Study ID Numbers: 1008032, 2010-019591-67
Study First Received: February 18, 2011
Last Updated: May 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
pain assessment
anesthesia
analgesia
opioid
 HRV
APV
autonomic nervous system (ANS)
pupil size

Additional relevant MeSH terms:
Anesthetics
Remifentanil
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on May 19, 2013