The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint : lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?
The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint is: lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
37
remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided
remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided
University Hospital Erasme (ULB)
Brussels, Belgium
Clinique privée d'ANTONY
Antony, France
University Hospital Claude Huriez
Lille, France
University Hospital Roger Salengro
Lille, France
University Hospital
Saint-Etienne, France
Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia
Time frame: end of surgery (around 60 to 90 min after start)
total administered remifentanil
Time frame: end of surgery
number of target changes
Time frame: end of surgery (around 60 to 90 min after start)
morphine sulfate total administration after end of surgery
Time frame: during two hours after end of surgery
Visual Analog Scale evaluation of pain after surgery
Time frame: during two hours after end of surgery
ANI measure during surgery
Time frame: from start to end of surgery (around 60 to 90 min)
number of bradycardia and hypotension
Time frame: from start to end of surgery (around 60 to 90 min )
total administered dose of ephedrine
Time frame: between start and end of anesthesia
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