To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.
Previous work has shown that NOL (Nociception Level) accurately quantifies nociception during general anesthesia.6 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 PACU (Post-Anesthesia Care Unit). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
72
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 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
PMD-200 Nociception level (NOL) values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
Cleveland Clinic
Cleveland, Ohio, United States
Pain Scores at 10-minute Intervals for the Initial Hour of Recovery
Pain scores are measured using a Verbal Response Scale (VRS) every 10 minutes in the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Time frame: At 10-minute intervals during the first 60 minutes after extubation.
Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery
Pain scores are measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Time frame: At 10-minute intervals during the first 30 minutes after extubation.
Number of Measurements With Pain Score Less Than 5 (vs ≥5) for Initial Hour of Recovery
Binary repeated-measures outcome of pain score will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Time frame: At 10-minute intervals during the first 60 minutes after extubation.
Number of Measurements With Pain Score Less Than 5 (vs ≥5) for the Initial 30 Minutes of Recovery
Binary repeated-measures outcome will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Time frame: At 10-minute intervals during the first 30 minutes after extubation.
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