NCT01893723

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 ?

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

June 18, 2013

Last Update Submit

April 16, 2026

Conditions

General Anesthesia

Keywords

autonomous nervous system monitoringanalgesia nociception balanceremifentanilanalgesia nociception indexhemodynamic reactivity

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia

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

Secondary Outcomes (7)

  • 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)

  • +2 more secondary outcomes

Study Arms (2)

ANI guided remifentanil arm

EXPERIMENTAL

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

ANI blind arm

OTHER

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

Interventions

ANI guided remifentanilPROCEDURE

remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided

ANI guided remifentanil arm
ANI blind armPROCEDURE

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

ANI blind arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • laparoscopic cholecystectomy or gynecological laparoscopic surgery
  • ASA I or II
  • adult patient
  • body mass index between 17 and 33 kg/m2

You may not qualify if:

  • pregnancy
  • arrhythmia
  • pace maker
  • diabetes mellitus
  • dysautonomia
  • treatment with beta blocking agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital Erasme (ULB)

Brussels, 1070, Belgium

Location

Clinique privée d'ANTONY

Antony, 92160, France

Location

University Hospital Claude Huriez

Lille, 59000, France

Location

University Hospital Roger Salengro

Lille, 59000, France

Location

University Hospital

Saint-Etienne, 42270, France

Location

Related Publications (1)

  • 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.

    PMID: 28268478RESULT

Study Officials

  • Mathieu JEANNE, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

July 9, 2013

Study Start

June 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2015

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

FR(4)BE(1)