Clinical trial NCT03556696: Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia
Official title: Automatic Remifentanil Administration Guided by the Analgesia Nociception Index During Propofol Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nociceptive Pain
Surgical Procedure, Unspecified
Keywords: general anesthesia
analgesia/nociception balance monitoring
expert system
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

Brief 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 ;

Eligibility criteria: 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

Primary outcomes:
measure: normalized remifentanil administration
timeFrame: During the surgery, an average Three hours and a half
Secondary outcomes:
measure: hemodynamic reactivity or bradycardia or hypotension
timeFrame: During the surgery, an average Three hours and a half
measure: total administered ephedrine
timeFrame: duration of general anesthesia
measure: Analgesia Nociception Index (ANI)
timeFrame: During the surgery, an average Three hours and a half
measure: Bispectral Index (BIS)
timeFrame: During the surgery, an average Three hours and a half
measure: Change antinociception/nociception balance status
timeFrame: 5 min before start of nociception, 5 min after start of nociception and 20 min after start of nociception
measure: Pain in PACU
timeFrame: During the first two postoperative hours
measure: morphine in PACU
timeFrame: During the first two postoperative hours
measure: ketamine in PACU
timeFrame: During the first two postoperative hours
measure: nausea/vomiting in PACU
timeFrame: During the first two postoperative hours
measure: remi target changes
timeFrame: During the surgery, an average Three hours and a half
measure: propofol target changes
timeFrame: During the surgery, an average Three hours and a half
measure: normalized propofol administration
timeFrame: During the surgery, an average Three hours and a half
measure: ANI-REMI-loop switch to manual
timeFrame: During the surgery, an average Three hours and a half
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Mathieu JEANNE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: