Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia (ANI-LOOP)

University Hospital, Lille

Status: Completed

Conditions: Surgical Procedure, Unspecified; Nociceptive Pain

Treatments: Drug: Propofol; Device: ANI-REMI-loop; Device: remifentanil pK/pD target administration device; Drug: Remifentanil; Device: ANI monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03556696

2017-A00858-45 (Other Identifier)

2016_48

Details and patient eligibility

About

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.

Full 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 ;

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

52 participants in 2 patient groups

ANI-loop

Experimental group

Description:

arm 1 : remifentanil is automatically administered by a medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France)

Treatment:

Device: ANI-REMI-loop

Drug: Propofol

Drug: Remifentanil

std_practice

Active Comparator group

Description:

arm 2: remifentanil is administered by a target control device using Minto's remifentanil pK/pD model. This is standard practice for this type of surgery at the Burn Center of the University Hospital of Lille, France.

Treatment:

Device: ANI monitor

Drug: Propofol

Device: remifentanil pK/pD target administration device

Drug: Remifentanil