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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMD-200 NOL group | Active Comparator | Clinicians will titrate fentanyl to keep PMD-200 (Pain Monitoring Device) Nociception level (NOL) under 25 - always using good clinical judgement for individual patients |
|
| Control Group | Active Comparator | Clinicians will be blinded to PMD-200 Nociception level (NOL) monitoring and use clinical judgement to determine how much fentanyl should be given, and when. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine opioid management | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At 10-minute intervals during the first 30 minutes after extubation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Analgesic Rescue Boluses | Number of analgesic rescue boluses in the first 60 minutes after extubation. | During the first 60 minutes after extubation. |
| Ramsay Scores During the First 60 Minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Ruetzler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36727855 | Derived | Ruetzler K, Montalvo M, Bakal O, Essber H, Rossler J, Mascha EJ, Han Y, Ramachandran M, Keebler A, Turan A, Sessler DI. Nociception Level Index-Guided Intraoperative Analgesia for Improved Postoperative Recovery: A Randomized Trial. Anesth Analg. 2023 Apr 1;136(4):761-771. doi: 10.1213/ANE.0000000000006351. Epub 2023 Jan 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PMD-200 NOL Group | Clinicians will titrate fentanyl to keep PMD-200 Nociception level (NOL) under 25 - always using good clinical judgement for individual patients PMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg actual body weight (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 |
| FG001 | Control Group | Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when. Routine opioid management: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PMD-200 NOL Group | Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients PMD-200 Nol-guided opioid administration: PMD-200 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Median | Inter-Quartile Range | score on a scale | At 10-minute intervals during the first 60 minutes after extubation. |
|
From the start of surgery to the initial hour of recovery.
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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 | PMD-200 NOL Group | Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients PMD-200 Nol-guided opioid administration: PMD-200 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Ruetzler | Cleveland Clinic | 216 636-0561 | ruetzlk@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2020 | Jan 29, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 5, 2021 | Jan 29, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| PMD-200 Nol-guided opioid administration | Device | 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 |
|
|
| 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. | At 10-minute intervals during the first 30 minutes after extubation. |
Ramsay scores will be measured using Ramsay Sedation Scale every 10 minutes in the initial hour of recovery. Ramsay Sedation Scale: 1 = Patient is anxious and agitated or restless, or both; 2 = Patient is co-operative, oriented, and tranquil; 3 = Patient responds to commands only; 4 = Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5 = Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6 = Patient exhibits no response. Frequencies for each score were reported.
| At 10-minute intervals during the first 60 minutes after extubation. |
| Treatment Effect on the Time to Emergence From Anesthesia. | Time to emergence from anesthesia is defined as minutes from discontinuation of sevoflurane anesthesia to extubation | From discontinuation of sevoflurane anesthesia to extubation intraoperatively, assessed up to the timepoint of leaving operation room. |
| BG001 | Control Group | Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when. Routine opioid management: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Procedure type | Count of Participants | Participants |
|
| Surgery type | Count of Participants | Participants |
|
| ASA (American Society of Anesthesiologist) physical status | ASA I: A normal healthy patient (better) ASA II: A patient with mild systemic disease ASA III: A patient with severe systemic disease (worse) | Count of Participants | Participants |
|
| Preoperative opioid use | Count of Participants | Participants |
|
| Preoperative antihypertension medication use | Count of Participants | Participants |
|
| OG001 | Control Group | Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when. Routine opioid management: 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. |
|
|
|
| Primary | 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. | Posted | Mean | Inter-Quartile Range | score on a scale | At 10-minute intervals during the first 30 minutes after extubation. |
|
|
|
|
| Secondary | 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. | Posted | Number | measurements | At 10-minute intervals during the first 60 minutes after extubation. | Measurements | Measurements |
|
|
|
|
| Secondary | 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. | Posted | Number | measurements | At 10-minute intervals during the first 30 minutes after extubation. | Measurements | Measurements |
|
|
|
|
| Other Pre-specified | Number of Analgesic Rescue Boluses | Number of analgesic rescue boluses in the first 60 minutes after extubation. | Posted | Median | Inter-Quartile Range | Number of boluses | During the first 60 minutes after extubation. |
|
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|
|
| Other Pre-specified | Ramsay Scores During the First 60 Minutes | Ramsay scores will be measured using Ramsay Sedation Scale every 10 minutes in the initial hour of recovery. Ramsay Sedation Scale: 1 = Patient is anxious and agitated or restless, or both; 2 = Patient is co-operative, oriented, and tranquil; 3 = Patient responds to commands only; 4 = Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5 = Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6 = Patient exhibits no response. Frequencies for each score were reported. | Posted | Number | Measurements | At 10-minute intervals during the first 60 minutes after extubation. | Measurements | Measurements |
|
|
|
|
| Other Pre-specified | Treatment Effect on the Time to Emergence From Anesthesia. | Time to emergence from anesthesia is defined as minutes from discontinuation of sevoflurane anesthesia to extubation | Posted | Median | Inter-Quartile Range | minutes | From discontinuation of sevoflurane anesthesia to extubation intraoperatively, assessed up to the timepoint of leaving operation room. |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control Group | Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when. Routine opioid management: 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. | 0 | 37 | 0 | 37 | 0 | 37 |
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| Time point 3 |
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| 3 (Patient responds to commands only) |
|
| 4 (Patient exhibits brisk response to light glabellar tap or loud auditory stimulus) |
|