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Previous work has shown that NOL (Medasense, Ramat Gan, Israel) accurately quantifies nociception during general anesthesia. Presumably, titrating opioids to NOL will therefore provide individual guidance so that patients will be given about the right amount. Patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the post anesthesia care unit (PACU). To the extent that NOL titration facilitates optimal opioid dosing, patients are likely to have better PACU experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine opioid management | Active Comparator | Clinicians will be blinded to NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when |
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| NOL-guided opioid administration | Experimental | Clinicians will titrate fentanyl to keep NOL under 25 - always using good clinical judgement for individual patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOL Guided Analgesia | Device | NOL values exceeding 25 will typically be treated with boluses of fentanyl 50 µg at roughly 5-minute intervals. The target will be maintained until surgery ends |
| Measure | Description | Time Frame |
|---|---|---|
| PACU pain score | Average pain scores (0-10 verbal response scale) at 10-minute intervals during the initial 60 minutes of recovery are more often between 1 and 3 or significantly lower with NOL-guided fentanyl than with routine care | 60 minutes during recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D059226 | Nociceptive Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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NOL-Guided analgesia vs. Routine Management
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Anesthesia clinicians cannot be blinded since they will need to titrate opioid administration to NOL. However, all postoperative care and evaluations will be fully blinded to randomization, thus preventing measurement bias
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| Routine opioid management | Other | Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 50 µg can be given per clinical judgement |
|