Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia
Condition: Nociceptive Pain; Surgical Procedure, Unspecified
MeSH terms: Nociceptive Pain
Study type: Interventional

Summary: 
      Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the
      study is to test whether the use of a medical device designed to automatically administer
      remifentanil during surgery based on expert rules and continuous reading of heart rate, blood
      pressure and the Analgesia Nociception Index results in lower overall remifentanil
      administration versus standard practice.
    

Detailed description: 
      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 ;
    

Intervention name(s): ANI-REMI-loop; remifentanil pK/pD target administration device; Remifentanil; Propofol; ANI monitor
Intervention type(s): Device; Device; Drug; Drug; Device
Intervention description(s): experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index for automatic remifentanil administration; standard practice, remifentanil administration using Minto's pK/pD model; Remifentanil Ce target can range from 0 to 10 ng.ml-1. Remifentanil target is adapted in order to maintain Analgesia Nociception Index (MDMS, Loos, France) in the [50-70] range.; propofol is used for induction and maintenance of general anesthesia using Schnider pK/pD model. Propofol Ce target is adapted in order to maintain BiSpectral Index in [40-60] range; ANI (Analgesia Nociception Index) value is used in the "std_practice" arm for guidance of the remifentanil Ce target
Other intervention name(s): PhysioDoloris (MDMS, Loos, France)
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Monocentric prospective randomized controlled clinical trial
arm 1: medical device automatically administering remifentanil, guided by expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France)
arm 2 : standard practice : remifentanil is administered using a target controlled device using a pK/pD model of Minto
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: general anesthesia; analgesia/nociception balance monitoring; expert system