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Clinical Trial 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 Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT01893723
Study type Interventional
Source University Hospital, Lille
Contact
Status Terminated
Phase N/A
Start date June 2012
Completion date May 2015

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