NCT03498820

Brief Summary

This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. The objective is to assess if the Analgesia Nociception Index may result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain and in chronic pain development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

November 19, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

February 26, 2018

Last Update Submit

May 21, 2021

Conditions

PainAnesthesia

Keywords

Analgesia-Nociception Index (ANI)General anesthesiaOpioidsRemifentanilPainMonitoring

Outcome Measures

Primary Outcomes (1)

  • Intraoperative remifentanil consumption

    total dose of remifentanil administered to the patient during general anesthesia

    up to 7 hours after the beginning of general anesthesia

Secondary Outcomes (3)

  • Postoperative morphine consumption

    obtained 24 hours after the end of general anesthesia

  • Persistent pain

    : obtained one month after surgery

  • Persistent pain

    Obtained three months after surgery

Study Arms (2)

Analgesia Nociception Index

EXPERIMENTAL

Intraoperative remifentanil administration guided by the Analgesia Nociception Index

Device: Analgesia Nociception Index

Usual practice

ACTIVE COMPARATOR

Intraoperative remifentanil administration managed in standard practice

Drug: Remifentanil

Interventions

Analgesia Nociception IndexDEVICE

: Non invasive monitor based on heart rate variability analysis, assessing the parasympathetic nervous activity

Also known as: ANI
Analgesia Nociception Index
RemifentanilDRUG

intravenous short-acting opioid routinely administered during general anesthesia

Usual practice

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective gynecological surgery under general anesthesia
  • Duration of surgery 1-7 hours
  • Duration of hospital stay \> 24 hours

You may not qualify if:

  • chronic pain
  • chronic analgesic medication
  • neurologic disease
  • psychiatric disease
  • history of addiction
  • kidney or liver failure
  • allergy to any anesthetic or analgesic drug
  • BMI \> 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Pain

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nada SABOURDIN, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 26, 2018

First Posted

April 17, 2018

Study Start

November 19, 2018

Primary Completion

December 19, 2019

Study Completion

March 13, 2020

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)