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The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.
Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression.
Assessment of the performance of ANI to detect NRS>3 and NRS>=7 by building ROC curves.
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| Measure | Description | Time Frame |
|---|---|---|
| Analgesia/Nociception Index (ANI) | The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less. | At arrival in post-operative care unit (PACU) or 10 min after extubation |
| Pain Scores on a 0-10 Numeric Rating Scale (NRS) | Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS<3 corresponds to no or mild pain NRS>=3 corresponds to moderate to severe pain NRS>=7 corresponds to severe pain | At arrival in PACU or 10 min after extubation |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients underoing surgical or endoscopic procedures performed on general anesthesia
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| Name | Affiliation | Role |
|---|---|---|
| Lionel Bouvet, MD | Édouard Herriot hospital, HCL | Principal Investigator |
| Gérard Bégou, MD | Édouard Herriot hospital, HCL | Principal Investigator |
| Rabia Dabouz, MD | Édouard Herriot hospital, HCL | Principal Investigator |
| Christophe Magnin, MD | Édouard Herriot hospital, HCL | Principal Investigator |
| Bernard Allaouchiche, MD, PhD | Édouard Herriot hospital, HCL | Study Chair |
| Emmanuel Boselli, MD, PhD | Édouard Herriot hospital, HCL | Study Director |
| Mirela-Daniela Ionescu, MD | Édouard Herriot hospital, HCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL | Lyon | 69003 | France |
No patient were excluded from the trial before assignment to groups
Study performed between June and July 2012 at Édouard Herriot university hospital,Lyon, France.
200 American Society of Anesthesiologists physical status I-II patients undergoing general anesthesia were included. The procedures performed were ear, nose and throat surgery or endoscopy and plastic surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | NRS<=3 (no or Mild Pain) | Patients with numerical rating pain scale <=3 at arrival in PACU |
| FG001 | NRS>3 (Moderate to Severe Pain) | Patients with numerical rating scale pain score >3 at arrival in PACU |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NRS<=3 | Patients with numerical rating scale <=3 at arrival in PACU |
| BG001 | NRS>3 | Patients with numerical rating scale pain score >3 at arrival in PACU |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Analgesia/Nociception Index (ANI) | The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less. | Posted | Mean | Standard Deviation | units on a scale | At arrival in post-operative care unit (PACU) or 10 min after extubation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NRS<=3 | Patients with numerical rating scale <=3 at arrival in PACU |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Emmanuel Boselli | Edouard Herriot hôspital Anaesthesia and intensive care | +334711689 | emmanuel.boselli@chu-lyon.fr |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Pain Scores on a 0-10 Numeric Rating Scale (NRS) | Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS<3 corresponds to no or mild pain NRS>=3 corresponds to moderate to severe pain NRS>=7 corresponds to severe pain | Posted | Mean | Standard Deviation | units on a scale | At arrival in PACU or 10 min after extubation |
|
|
|
| 0 |
| 132 |
| 0 |
| 132 |
| EG001 | NRS>3 | Patients with numerical rating scale pain score >3 at arrival in PACU | 0 | 68 | 0 | 68 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |