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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03556696
Other study ID # 2016_48
Secondary ID 2017-A00858-45
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2018
Est. completion date November 22, 2022

Study information

Verified date November 2022
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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 ;


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date November 22, 2022
Est. primary completion date June 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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
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.
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

Locations

Country Name City State
France Hôpital Roger Salengro, CHU Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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