Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia

Not Applicable

Completed

• Conditions: Nociceptive Pain; Surgical Procedure, Unspecified
• Interventions: Device: remifentanil pK/pD target administration device; Device: ANI-REMI-loop; Drug: Remifentanil; Drug: Propofol; Device: ANI monitor

• Registration Number: NCT03556696
• Lead Sponsor: University Hospital, Lille

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 ;

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-06-13
• Study First Posted: 2018-06-14
• Study Start: 2018-06-27
• Primary Completion: 2022-06-14
• Status Verified: 2022-11
• Study Completion: 2022-11-22
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
std_practice	remifentanil pK/pD target administration device	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.
ANI-loop	ANI-REMI-loop	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)
std_practice	ANI monitor	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.
ANI-loop	Remifentanil	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)
ANI-loop	Propofol	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)
std_practice	Remifentanil	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.
std_practice	Propofol	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.

Primary Outcome Measures

Name	Time	Method
normalized remifentanil administration	During the surgery, an average Three hours and a half	ratio of total amount of administered remifentanil with body weight and duration of administration

Secondary Outcome Measures

Name	Time	Method
hemodynamic reactivity or bradycardia or hypotension	During the surgery, an average Three hours and a half	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.
Analgesia Nociception Index (ANI)	During the surgery, an average Three hours and a half	relative amount of time spent with ANIi in the \[0-50\], \[50-70\] and \[70-100\] windows. Same with ANIm
remi target changes	During the surgery, an average Three hours and a half	total number of target changes during general anesthesia
propofol target changes	During the surgery, an average Three hours and a half	total number of target changes during general anesthesia
ANI-REMI-loop switch to manual	During the surgery, an average Three hours and a half	number of interventions on ANI-REMI-loop device: switch to manual
total administered ephedrine	duration of general anesthesia	total amount of ephedrine administered during general anesthesia
Pain in PACU	During the first two postoperative hours	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).
ketamine in PACU	During the first two postoperative hours	Total amount of administered ketamine during PACU stay
nausea/vomiting in PACU	During the first two postoperative hours	reported number of nausea/vomiting during PACU stay
Bispectral Index (BIS)	During the surgery, an average Three hours and a half	relative amount of time spent with BIS in the \[0-40\], \[40-60\] and \[60-100\] windows.
Change antinociception/nociception balance status	5 min before start of nociception, 5 min after start of nociception and 20 min after start of nociception	composite measure: heart rate, blood pressure, ANIi, ANIm, end-tidal CO2, PeakPressure
morphine in PACU	During the first two postoperative hours	Total amount of administered morphine during PACU stay
normalized propofol administration	During the surgery, an average Three hours and a half	ratio of total amount of propofol administered with body weight and duration of general anesthesia

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France