Pain Assessment During General Anesthesia (DOLANS)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: opioid (remifentanyl)

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42100
    • CHU DE SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in HRV measurements during noxious stimulation	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.	baseline and 5 minutes
change from baseline in APV measurements during noxious stimulation	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.	baseline and 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pupil change during noxious stimulation	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	baseline and 5 minutes
change from baseline in heart rate during noxious stimulation	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.	baseline and 5 minutes
Change from baseline in BIS (Bispectral Index) during noxious stimulation	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	baseline and 5 minutes
change from baseline in systolic blood pressure during noxious baseline	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	baseline and 5 minutes
Change from baseline in diastolic blood pressure during noxious stimulation	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	basline and 5 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: David Charier, CHU DE SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): May 17, 2012
• Last Update Submitted That Met QC Criteria: May 16, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: opioid; anesthesia; pain assessment; analgesia; HRV; APV; autonomic nervous system (ANS); pupil size
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 1008032; 2010-019591-67 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No