Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia

University Hospital, Lille52 enrolled

Overview

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.

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 ;

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Nociceptive Pain Surgical Procedure, Unspecified

Interventions

ANI-REMI-loopDEVICE

experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index for automatic remifentanil administration

remifentanil pK/pD target administration deviceDEVICE

standard practice, remifentanil administration using Minto's pK/pD model

RemifentanilDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Roger Salengro, CHU

Lille, France

Outcomes

Primary Outcomes

normalized remifentanil administration

ratio of total amount of administered remifentanil with body weight and duration of administration

Time frame: During the surgery, an average Three hours and a half

Secondary Outcomes

hemodynamic reactivity or bradycardia or hypotension

relative amount of time during which heart rate or SBP exceed 120% of baseline, or heart rate drops below 40/min, or SBP drops below 75 mmHg.

Time frame: During the surgery, an average Three hours and a half

total administered ephedrine

total amount of ephedrine administered during general anesthesia

Time frame: duration of general anesthesia

Analgesia Nociception Index (ANI)

relative amount of time spent with ANIi in the \[0-50\], \[50-70\] and \[70-100\] windows. Same with ANIm

Time frame: During the surgery, an average Three hours and a half

Bispectral Index (BIS)

relative amount of time spent with BIS in the \[0-40\], \[40-60\] and \[60-100\] windows.

Time frame: During the surgery, an average Three hours and a half

Change antinociception/nociception balance status

composite measure: heart rate, blood pressure, ANIi, ANIm, end-tidal CO2, PeakPressure

Time frame: 5 min before start of nociception, 5 min after start of nociception and 20 min after start of nociception

Pain in PACU

Visual Analog Scale every 15 min in PACU The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme (0, 10).

Data from ClinicalTrials.gov

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