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NCT Number: NCT01893723

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

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 ?

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Key information

Conditions

General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Erasme (ULB), Brussels, Belgium

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About this study

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 ?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANI guided remifentanil

Procedure

remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided

ANI blind arm

Procedure

remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided

Primary outcomes

  1. 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)

Secondary outcomes

  1. total administered remifentanil

    Time frame: end of surgery

  2. number of target changes

    Time frame: end of surgery (around 60 to 90 min after start)

  3. morphine sulfate total administration after end of surgery

    Time frame: during two hours after end of surgery

  4. Visual Analog Scale evaluation of pain after surgery

    Time frame: during two hours after end of surgery

  5. ANI measure during surgery

    Time frame: from start to end of surgery (around 60 to 90 min)

  6. number of bradycardia and hypotension

    Time frame: from start to end of surgery (around 60 to 90 min )

  7. total administered dose of ephedrine

    Time frame: between start and end of anesthesia

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: AIVOC-ANI

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 9, 2013
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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