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

This study has been terminated.
(Changes of usual clinical practices)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01893723
First Posted: July 9, 2013
Last Update Posted: November 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Lille
  Purpose
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 ?

Condition Intervention
General Anesthesia Procedure: ANI guided remifentanil Procedure: ANI blind arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • total administered remifentanil [ Time Frame: end of surgery ]
  • number of target changes [ Time Frame: end of surgery (around 60 to 90 min after start) ]
  • morphine sulfate total administration after end of surgery [ Time Frame: during two hours after end of surgery ]
  • Visual Analog Scale evaluation of pain after surgery [ Time Frame: during two hours after end of surgery ]
  • ANI measure during surgery [ Time Frame: from start to end of surgery (around 60 to 90 min) ]
  • number of bradycardia and hypotension [ Time Frame: from start to end of surgery (around 60 to 90 min ) ]
  • total administered dose of ephedrine [ Time Frame: between start and end of anesthesia ]

Enrollment: 37
Study Start Date: June 2012
Study Completion Date: May 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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 ?
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01893723


Locations
Belgium
University Hospital Erasme (ULB)
Brussel, Belgium, 1070
France
Clinique privée d'ANTONY
Antony, France, 92160
University Hospital Claude Huriez
Lille, France, 59000
University Hospital Roger Salengro
Lille, France, 59000
University Hospital
Saint Etienne, France, 42270
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Mathieu JEANNE, MD University Hospital, Lille
  More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01893723     History of Changes
Other Study ID Numbers: 2010_51
2011-A00947-34 ( Other Identifier: ID-RCB number, ANSM )
First Submitted: June 18, 2013
First Posted: July 9, 2013
Last Update Posted: November 4, 2015
Last Verified: November 2015

Keywords provided by University Hospital, Lille:
autonomous nervous system monitoring
analgesia nociception balance
remifentanil
analgesia nociception index
hemodynamic reactivity

Additional relevant MeSH terms:
Anesthetics
Propofol
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents