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Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice:Evaluation of Perioperative Opioid Use (MONIDOL-ANI)

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ClinicalTrials.gov Identifier: NCT03498820
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Pain Anesthesia Device: Analgesia Nociception Index Drug: Remifentanil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice : Evaluation of Perioperative Opioid Use
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Analgesia Nociception Index
Intraoperative remifentanil administration guided by the Analgesia Nociception Index
Device: Analgesia Nociception Index
: Non invasive monitor based on heart rate variability analysis, assessing the parasympathetic nervous activity
Other Name: ANI

Active Comparator: Usual practice
Intraoperative remifentanil administration managed in standard practice
Drug: Remifentanil
intravenous short-acting opioid routinely administered during general anesthesia




Primary Outcome Measures :
  1. Intraoperative remifentanil consumption [ Time Frame: up to 7 hours after the beginning of general anesthesia ]
    total dose of remifentanil administered to the patient during general anesthesia


Secondary Outcome Measures :
  1. Postoperative morphine consumption [ Time Frame: obtained 24 hours after the end of general anesthesia ]
    total dose of morphine administered to the patient to manage postoperative pain during the first 24 hours following surgery

  2. Persistent pain [ Time Frame: : obtained one month after surgery ]
    phone interview asking the patient if she still feels pain related to the surgery

  3. Persistent pain [ Time Frame: Obtained three months after surgery ]
    phone interview asking the patient if she still feels pain related to the surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498820


Contacts
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Contact: Nada SABOURDIN, MD +33 1 71 73 89 76 nada.sabourdin@aphp.fr
Contact: Isabelle CONSTANT, PU-PH +33 1 71 73 89 44 isabelle.constant@aphp.fr

Locations
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France
Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau Recruiting
Paris, France, 75012
Contact: Nada SABOURDIN, MD    +33 1 71 73 89 76    nada.sabourdin@aphp.fr   
Contact: Isabelle CONSTANT, PU-PH    +33 1 71 73 89 44    isabelle.constant@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Nada SABOURDIN, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03498820    
Other Study ID Numbers: P171003J
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Analgesia-Nociception Index (ANI)
General anesthesia
Opioids
Remifentanil
Pain
Monitoring
Additional relevant MeSH terms:
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Analgesics, Opioid
Remifentanil
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents