Pain Assessment During General Anesthesia

NCT01303471 | Completed

• 2 other identifiers: 10080322010-019591-67
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain assessment; anesthesia; analgesia; opioid; HRV; APV; autonomic nervous system (ANS); pupil size

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 Arms (1)

opioïd

EXPERIMENTAL

Different levels of remifentanyl of each group during nociceptive stimulation

Drug: opioid (remifentanyl)

Interventions

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)

opioïd

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Analgesics, Opioid; Remifentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Charier

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 24, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

FR (1)