Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery
Information source: University Hospital, Lille
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: General Anesthesia
Intervention: ANI guided remifentanil (Procedure); ANI blind arm (Procedure)
Phase: N/A
Status: Terminated
Sponsored by: University Hospital, Lille Official(s) and/or principal investigator(s):
Mathieu JEANNE, MD, Principal Investigator, Affiliation: University Hospital, Lille
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 ?
Clinical Details
Official title: Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Primary outcome: Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia
Secondary outcome: total administered remifentanilnumber of target changes morphine sulfate total administration after end of surgery Visual Analog Scale evaluation of pain after surgery ANI measure during surgery number of bradycardia and hypotension total administered dose of ephedrine
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University Hospital Erasme (ULB), Brussel 1070, Belgium
Clinique privée d'ANTONY, Antony 92160, France
University Hospital Claude Huriez, Lille 59000, France
University Hospital Roger Salengro, Lille 59000, France
University Hospital, Saint Etienne 42270, France
Additional Information
Starting date: June 2012
Last updated: December 9, 2014
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