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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01645-40 | Other Identifier | ID-RCB number,ANSM |
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The purpose of this study is to determine whether the value of analgesia nociception index (ANI) is influenced by variations of systemic venous return (cardiac preload) under general anaesthesia.
In the context of opioid sparing goal during general anaesthesia, the Analgesia nociception index (ANI) is an analgesia/nociception balance monitoring tool computed from high frequency heart rate variability analysis, and developed by MetroDoloris (Lille, France). Its sensitivity to detect noxious stimulus was studied in several studies. However, its specificity is not established in particular in the presence of factors influencing autonomic nervous system other than analgesia/nociception balance. In the context of anaesthesia, one of the most relevant factor is hypovolemia. This study aims to assess the effect of blood volume variations on ANI under general anaesthesia, independently of analgesia/nociception balance status. Variations of systemic venous return (SVR) (cardiac preload), which reflects blood volume status, will be induced by changes of operating table slope, from head-down tilt (Trendelenburg), with increased SVR, to head-up tilt position, with decreased SVR. Variations of SVR will be attested by changes in the arterial pulse pressure variation, a well-established indice of preload responsiveness in the mechanically ventilated anaesthetized patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| noxious stimulus | Procedure | standardized noxious stimulus with tetanic stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position | Position -20° to +20° | during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions) |
| Measure | Description | Time Frame |
|---|---|---|
| change in ANI between horizontal position and head-down/head up tilt position | Position 0° to -20° Position +20° to 0° | during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions) |
| change in pulse pressure variation between head-down tilt position and head-up tilt position |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoît Tavernier, Pr | University Hospital, Lille | Principal Investigator |
| Délégation à la Recherche Clinique et à l'Innovation (DRC) | University Hospital, Lille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Lille | Nord | 59000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26817405 | Result | Lamer A, Jeanne M, Marcilly R, Kipnis E, Schiro J, Logier R, Tavernier B. Methodology to automatically detect abnormal values of vital parameters in anesthesia time-series: Proposal for an adaptable algorithm. Comput Methods Programs Biomed. 2016 Jun;129:160-71. doi: 10.1016/j.cmpb.2016.01.004. Epub 2016 Jan 14. |
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| change in operating table slope: head-down tilt position |
| Procedure |
-30° |
|
|
| change in operating table slope: head-up tilt position | Procedure | +30° |
|
Position -20° to +20° |
| during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions) |
| change in ANI induced by standardized noxious stimulus (tetanic stimulation) | ANI measurement following tetanus | during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions) |
| variations of low frequency variability of arterial blood pressure | Position 0° to -20° Position -20° to +20° Position +20° to 0° | during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions) |
| change in pulse pressure variation between horizontal position and head-down/head up tilt position | Position 0° to -20° Position +20° to 0° | during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions) |
| ID | Term |
|---|---|
| D020896 | Hypovolemia |
| D059226 | Nociceptive Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D018475 | Head-Down Tilt |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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