Trial record 7 of 32 for:    Open Studies | "Pain Perception"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University Hospital, Lille
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01893723
First received: June 18, 2013
Last updated: July 2, 2013
Last verified: July 2013
  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 Blind (Subject)
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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total administered remifentanil [ Time Frame: end of surgery ] [ Designated as safety issue: No ]
  • number of target changes [ Time Frame: end of surgery (around 60 to 90 min after start) ] [ Designated as safety issue: No ]
  • morphine sulfate total administration after end of surgery [ Time Frame: during two hours after end of surgery ] [ Designated as safety issue: No ]
  • Visual Analog Scale evaluation of pain after surgery [ Time Frame: during two hours after end of surgery ] [ Designated as safety issue: No ]
  • ANI measure during surgery [ Time Frame: from start to end of surgery (around 60 to 90 min) ] [ Designated as safety issue: No ]
  • number of bradycardia and hypotension [ Time Frame: from start to end of surgery (around 60 to 90 min ) ] [ Designated as safety issue: No ]
  • total administered dose of ephedrine [ Time Frame: between start and end of anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893723

Contacts
Contact: Mathieu JEANNE, MD +33 3 20 44 40 74 mathieu.jeanne@chru-lille.fr

Locations
Belgium
University Hospital Erasme (ULB) Recruiting
Brussel, Belgium, 1070
Contact: Luc BARVAIS, Prof       luc.barvais@erasme.ulb.ac.be   
Principal Investigator: Luc BARVAIS, Prof         
France
University Hospital Claude Huriez Recruiting
Lille, France, 59000
Contact: Gilles LEBUFFE, Pr    +33 3 20 44 45 08    gilles.lebuffe@chru-lille.fr   
Principal Investigator: Gilles LEBUFFE, Pr         
University Hospital Roger Salengro Recruiting
Lille, France, 59000
Contact: Mathieu JEANNE, MD    +33 3 20 44 40 74    mathieu.jeanne@chru-lille.fr   
Principal Investigator: Mathieu JEANNE, MD         
University Hospital Recruiting
Saint Etienne, France, 42270
Contact: Serge MOLLIEX, Pr    +33 4 77 12 03 88    serge.molliex@chu-st-etienne.fr   
Principal Investigator: Serge MOLLIEX, Pr         
Sponsors and Collaborators
University Hospital, Lille
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01893723     History of Changes
Other Study ID Numbers: 2011-A00947-34
Study First Received: June 18, 2013
Last Updated: July 2, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014