Nociceptive Pain, Surgical Procedure, Unspecified
Conditions
Keywords
general anesthesia, analgesia/nociception balance monitoring, expert system
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 ;
Interventions
DEVICEANI-REMI-loop
experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index for automatic remifentanil administration
DEVICEremifentanil pK/pD target administration device
standard practice, remifentanil administration using Minto's pK/pD model
DRUGRemifentanil
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.
DRUGPropofol
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
DEVICEANI monitor
ANI (Analgesia Nociception Index) value is used in the "std\_practice" arm for guidance of the remifentanil Ce target
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Monocentric prospective randomized controlled clinical trial * arm 1: medical device automatically administering remifentanil, guided by expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France) * arm 2 : standard practice : remifentanil is administered using a target controlled device using a pK/pD model of Minto
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| total administered ephedrine | duration of general anesthesia | total amount of ephedrine administered during general anesthesia |
| 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 |
| 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 |
| 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). |
| morphine in PACU | During the first two postoperative hours | Total amount of administered morphine during PACU stay |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMathieu JEANNE, MD,PhD
University Hospital, Lille
Outcome results
None listed