NCT03556696

Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia

Automatic Remifentanil Administration Guided by the Analgesia Nociception Index During Propofol Anesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 ;

Conditions

• Nociceptive Pain
• Surgical Procedure, Unspecified

Interventions

Type	Name	Description
DEVICE	ANI-REMI-loop	experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index for automatic remifentanil administration
DEVICE	remifentanil pK/pD target administration device	standard practice, remifentanil administration using Minto's pK/pD model
DRUG	Remifentanil	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.
DRUG	Propofol	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
DEVICE	ANI monitor	ANI (Analgesia Nociception Index) value is used in the "std\_practice" arm for guidance of the remifentanil Ce target

Timeline

• Start date: 2018-06-27
• Primary completion: 2022-06-14
• Completion: 2022-11-22
• First posted: 2018-06-14
• Last updated: 2026-02-20

Locations

1 site across 1 country: France