General Anesthesia
Conditions
Keywords
autonomous nervous system monitoring, analgesia nociception balance, remifentanil, analgesia nociception index, hemodynamic reactivity
Brief summary
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 ?
Detailed description
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 ?
Interventions
PROCEDUREANI guided remifentanil
remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided
PROCEDUREANI blind arm
remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* laparoscopic cholecystectomy or gynecological laparoscopic surgery * ASA I or II * adult patient * body mass index between 17 and 33 kg/m2
Exclusion criteria
* pregnancy * arrhythmia * pace maker * diabetes mellitus * dysautonomia * treatment with beta blocking agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia | end of surgery (around 60 to 90 min after start) |
Secondary
| Measure | Time frame |
|---|---|
| total administered remifentanil | end of surgery |
| number of target changes | end of surgery (around 60 to 90 min after start) |
| morphine sulfate total administration after end of surgery | during two hours after end of surgery |
| Visual Analog Scale evaluation of pain after surgery | during two hours after end of surgery |
| ANI measure during surgery | from start to end of surgery (around 60 to 90 min) |
| number of bradycardia and hypotension | from start to end of surgery (around 60 to 90 min ) |
| total administered dose of ephedrine | between start and end of anesthesia |
Countries
Belgium, France
Contacts
PRINCIPAL_INVESTIGATORMathieu JEANNE, MD
University Hospital, Lille
Outcome results
None listed