Pain Assessment During General Anesthesia

Pain Clinical Trial

— DOLANS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303471
• Other study ID #: 1008032
• Secondary ID: 2010-019591-67
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: May 16, 2012
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: May 2012
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pain

Intervention

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)

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No