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Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia — ANI-LOOP  

Surgical Procedure, Unspecified Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03556696
Study type Interventional
Source University Hospital, Lille
Contact
Status Completed
Phase N/A
Start date June 27, 2018
Completion date November 22, 2022
View Details
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