Clinical trial NCT01893723: Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery
Official title: Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: General Anesthesia
Keywords: autonomous nervous system monitoring
analgesia nociception balance
remifentanil
analgesia nociception index
hemodynamic reactivity
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 ?

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia
timeFrame: end of surgery (around 60 to 90 min after start)
Secondary outcomes:
measure: total administered remifentanil
timeFrame: end of surgery
measure: number of target changes
timeFrame: end of surgery (around 60 to 90 min after start)
measure: morphine sulfate total administration after end of surgery
timeFrame: during two hours after end of surgery
measure: Visual Analog Scale evaluation of pain after surgery
timeFrame: during two hours after end of surgery
measure: ANI measure during surgery
timeFrame: from start to end of surgery (around 60 to 90 min)
measure: number of bradycardia and hypotension
timeFrame: from start to end of surgery (around 60 to 90 min )
measure: total administered dose of ephedrine
timeFrame: between start and end of anesthesia
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: University Hospital Erasme (ULB)
city: Antony
country: France
facility: Clinique privée d'ANTONY
city: Lille
country: France
facility: University Hospital Claude Huriez
city: Lille
country: France
facility: University Hospital Roger Salengro
city: Saint Etienne
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Lille
name: Mathieu JEANNE, MD
role: PRINCIPAL_INVESTIGATOR
References: