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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A00858-45 | Other Identifier | ID-RCB number, ANSM |
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Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception Index results in lower overall remifentanil administration versus standard practice.
Prospective Randomized Monocentric Clinical Trial during propofol anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANI-loop | Experimental | arm 1 : remifentanil is automatically administered by a medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France) |
|
| std_practice | Active Comparator | arm 2: remifentanil is administered by a target control device using Minto's remifentanil pK/pD model. This is standard practice for this type of surgery at the Burn Center of the University Hospital of Lille, France. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANI-REMI-loop | Device | experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index for automatic remifentanil administration |
| Measure | Description | Time Frame |
|---|---|---|
| normalized remifentanil administration | ratio of total amount of administered remifentanil with body weight and duration of administration | During the surgery, an average Three hours and a half |
| Measure | Description | Time Frame |
|---|---|---|
| hemodynamic reactivity or bradycardia or hypotension | relative amount of time during which heart rate or SBP exceed 120% of baseline, or heart rate drops below 40/min, or SBP drops below 75 mmHg. | During the surgery, an average Three hours and a half |
| total administered ephedrine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathieu JEANNE, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro, CHU | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30440445 | Result | De Jonckheere J, Jeanne M, Keribedj A, Delecroix M, Logier R. Closed-loop administration of analgesic drugs based on heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:506-509. doi: 10.1109/EMBC.2018.8512330. |
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| ID | Term |
|---|---|
| D059226 | Nociceptive Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Monocentric prospective randomized controlled clinical trial
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| remifentanil pK/pD target administration device | Device | standard practice, remifentanil administration using Minto's pK/pD model |
|
| Remifentanil | Drug | Remifentanil Ce target can range from 0 to 10 ng.ml-1. Remifentanil target is adapted in order to maintain Analgesia Nociception Index (MDMS, Loos, France) in the [50-70] range. |
|
| Propofol | Drug | propofol is used for induction and maintenance of general anesthesia using Schnider pK/pD model. Propofol Ce target is adapted in order to maintain BiSpectral Index in [40-60] range |
|
| ANI monitor | Device | ANI (Analgesia Nociception Index) value is used in the "std_practice" arm for guidance of the remifentanil Ce target |
|
|
total amount of ephedrine administered during general anesthesia |
| duration of general anesthesia |
| Analgesia Nociception Index (ANI) | relative amount of time spent with ANIi in the [0-50], [50-70] and [70-100] windows. Same with ANIm | During the surgery, an average Three hours and a half |
| Bispectral Index (BIS) | relative amount of time spent with BIS in the [0-40], [40-60] and [60-100] windows. | During the surgery, an average Three hours and a half |
| Change antinociception/nociception balance status | composite measure: heart rate, blood pressure, ANIi, ANIm, end-tidal CO2, PeakPressure | 5 min before start of nociception, 5 min after start of nociception and 20 min after start of nociception |
| Pain in PACU | Visual Analog Scale every 15 min in PACU The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme (0, 10). | During the first two postoperative hours |
| morphine in PACU | Total amount of administered morphine during PACU stay | During the first two postoperative hours |
| ketamine in PACU | Total amount of administered ketamine during PACU stay | During the first two postoperative hours |
| nausea/vomiting in PACU | reported number of nausea/vomiting during PACU stay | During the first two postoperative hours |
| remi target changes | total number of target changes during general anesthesia | During the surgery, an average Three hours and a half |
| propofol target changes | total number of target changes during general anesthesia | During the surgery, an average Three hours and a half |
| normalized propofol administration | ratio of total amount of propofol administered with body weight and duration of general anesthesia | During the surgery, an average Three hours and a half |
| ANI-REMI-loop switch to manual | number of interventions on ANI-REMI-loop device: switch to manual | During the surgery, an average Three hours and a half |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |