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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00947-34 | Other Identifier | ID-RCB number, ANSM |
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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 ?
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 ?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANI guided remifentanil arm | Experimental | remifentanil targets are increased or decreased depending on ANI readings. In case of high blood pressure associated with elevated ANI, nicardipine is administered. |
|
| ANI blind arm | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANI guided remifentanil | Procedure | remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia | end of surgery (around 60 to 90 min after start) |
| Measure | Description | Time Frame |
|---|---|---|
| total administered remifentanil | end of surgery | |
| number of target changes | end of surgery (around 60 to 90 min after start) | |
| morphine sulfate total administration after end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathieu JEANNE, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Erasme (ULB) | Brussels | 1070 | Belgium | |||
| Clinique privée d'ANTONY |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28268478 | Result | Logier R, De Jonckheere J, Dassonneville A, Jeanne M. Comparison of pulse rate variability and heart rate variability for high frequency content estimation. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:936-939. doi: 10.1109/EMBC.2016.7590855. |
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| ANI blind arm | Procedure | remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided |
|
| during two hours after end of surgery |
| Visual Analog Scale evaluation of pain after surgery | during two hours after end of surgery |
| ANI measure during surgery | from start to end of surgery (around 60 to 90 min) |
| number of bradycardia and hypotension | from start to end of surgery (around 60 to 90 min ) |
| total administered dose of ephedrine | between start and end of anesthesia |
| Antony |
| 92160 |
| France |
| University Hospital Claude Huriez | Lille | 59000 | France |
| University Hospital Roger Salengro | Lille | 59000 | France |
| University Hospital | Saint-Etienne | 42270 | France |