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

• ClinicalTrials.gov Identifier: NCT01893723
• Recruitment Status: Terminated
• First Posted: July 9, 2013
• Last Update Posted: November 4, 2015
• Sponsor: University Hospital, Lille
• Information provided by (Responsible Party): University Hospital, Lille

Tracking Information

• First Submitted Date: June 18, 2013
• First Posted Date: July 9, 2013
• Last Update Posted Date: November 4, 2015
• Study Start Date: June 2012
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 2, 2013): 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) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 2, 2013)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery
• Official Title: Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial
• 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 ?
• 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 ?
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Diagnostic
• Condition: General Anesthesia

Intervention

• Procedure: ANI guided remifentanil
  remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided
• Procedure: ANI blind arm
  remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided

Study Arms

• 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.
  Intervention: Procedure: ANI guided remifentanil
• 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.
  Intervention: Procedure: ANI blind arm

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 8, 2014): 37
• Original Estimated Enrollment (submitted: July 2, 2013): 164
• Actual Study Completion Date: May 2015
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France

Administrative Information

• NCT Number: NCT01893723
• Other Study ID Numbers: 2010_51; 2011-A00947-34 ( Other Identifier: ID-RCB number, ANSM )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Lille
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Lille
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mathieu JEANNE, MD; University Hospital, Lille

• PRS Account: University Hospital, Lille
• Verification Date: November 2015