Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia

Prospective Randomized Monocentric Clinical Trial during propofol anesthesia.

• inclusion: ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery in a Burn Center (University Hospital of Lille, France)
• arm 1 : Remifentanil will be automatically administered by an expert system guided by heart rate, blood pressure and the Analgesia Nociception Index (ANI).
• arm 2 : Remifentanil will be administered by a target controlled device using the Minto pK/pD model.
• propofol is administered throughout the procedure with a target controlled device using the pK/pD model of Schnider. The target will be guided by the BiSpectral index values.
• primary endpoint : overall normalized remifentanil administration.
• secondary endpoints : relative amount of time spent in a state of hemodynamic reactivity ; relative amount of time the ANI spends in the [0-50], [50-70] and [70-100] windows ; relative amount of time the BIS spends in the [0-40], [40-60] and [60-100] ; hemodynamic status at various times during anesthesia ; total amount of target modifications of remifentanil and propofol ; total amount of morphine administered in PACU ; total amount of ketamine administered in PACU ; incidence of nausea/vomiting in PACU ;

Inclusion criteria

• ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery at the Burn Center of the University Hospital of Lille

Exclusion criteria

• BMI outside [17 - 35 kg/m2]
• pregnancy or breast feeding women
• non sinus cardiac rhythm
• documented dysautonomia
• complicated diabetes mellitus
• known allergy to a drug used in the clinical trial