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Pain Assessment During General Anesthesia (DOLANS)

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Pain

Treatments

Drug: opioid (remifentanyl)

Study type

Interventional

Funder types

Other

Identifiers

NCT01303471
1008032
2010-019591-67 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

75 participants in 1 patient group

opioïd
Experimental group
Description:
Different levels of remifentanyl of each group during nociceptive stimulation
Treatment:
Drug: opioid (remifentanyl)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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