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Clinical Trials/NCT01303471
NCT01303471
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country75 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
opioid (remifentanyl)
Conditions
Pain
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
75
Locations
1
Primary Endpoint
Change from baseline in HRV measurements during noxious stimulation
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
January 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility 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
  • obesity (BMI\>30 kg/m2)
  • medication altering autonomic nervous system tone
  • history of eyes surgery

Arms & Interventions

opioïd

Different levels of remifentanyl of each group during nociceptive stimulation

Intervention: opioid (remifentanyl)

Outcomes

Primary Outcomes

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.

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

  • Change from baseline in pupil change during noxious stimulation(baseline and 5 minutes)
  • change from baseline in heart rate during noxious stimulation(baseline and 5 minutes)
  • Change from baseline in BIS (Bispectral Index) during noxious stimulation(baseline and 5 minutes)
  • change from baseline in systolic blood pressure during noxious baseline(baseline and 5 minutes)
  • Change from baseline in diastolic blood pressure during noxious stimulation(basline and 5 minutes)

Study Sites (1)

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