Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery (AIVOC-ANI)

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

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 ?

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: Procedure: ANI guided remifentanil; Procedure: ANI blind arm

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 ?

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • University Hospital Erasme (ULB)
• France
  • Antony, France, 92160
    • Clinique privée d'ANTONY
  • Lille, France, 59000
    • University Hospital Claude Huriez
  • Lille, France, 59000
    • University Hospital Roger Salengro
  • Saint-Etienne, France, 42270
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANI guided remifentanil arm; 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; remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided
Other: ANI blind arm; 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; remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Mathieu JEANNE, MD, University Hospital, Lille

Publications and helpful links

General Publications

• Logier R, De Jonckheere J, Dassonneville A, Jeanne M. Comparison of pulse rate variability and heart rate variability for high frequency content estimation. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:936-939. doi: 10.1109/EMBC.2016.7590855.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 18, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimated): July 9, 2013

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: remifentanil; analgesia nociception index; autonomous nervous system monitoring; analgesia nociception balance; hemodynamic reactivity
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 2010_51; 2011-A00947-34 (Other Identifier: ID-RCB number, ANSM)