Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery

Study Overview
=================
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 ?

Official Title
-----------------
Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Procedure: ANI guided remifentanil
* Procedure: ANI blind arm


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANI guided remifentanil arm<br>remifentanil targets are increased or decreased depending on ANI readings. In case of high blood pressure associated with elevated ANI, nicardipine is administered. | Procedure: ANI guided remifentanil<br>* remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided<br>|
| Other: ANI blind arm<br>remifentanil target is adapted as is usual during general anesthesia, depending on hemodynamic reactions to nociceptive surgical stimulations. In case of elevated blood pressure despite a maximum target of 10 ng/ml (Minto Pk/pD model), then nicardipine is administered. | Procedure: ANI blind arm<br>* remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autonomous nervous system monitoring, analgesia nociception balance, remifentanil, analgesia nociception index, hemodynamic reactivity