Anesthesia; Adverse EffectPhase 3NCT04679818
Postoperative Consequences of Intraoperative NOL Titration
A Phase 3 study testing Routine opioid management and PMD-200 Nol-guided opioid administration in people with Anesthesia; Adverse Effect, run by The Cleveland Clinic at 1 site in United States.
Trial summary
To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Anesthesia; Adverse Effect
- What is being tested?
- Routine opioid management and PMD-200 Nol-guided opioid administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2020to 10 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults having major non-cardiac surgery expected to last ≥2 hours
- American Society of Anesthesiologists physical status 1-3
- Age 21-85 years old
- Planned endotracheal intubation
Who cannot join
- Planned neuraxial or regional block
- Clinician preference for an opioid other than, or in addition to, fentanyl
- Non-sinus heart
- Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea
- Lack of English language fluency
- Routine user of psychoactive drugs other than opioids
Show all 9Show fewer
- Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.
- Intracranial surgery.
- BMI > 40
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.
Read the detailed description
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.
- Conditions
- Anesthesia; Adverse Effect
- Being tested
- Routine opioid management, PMD-200 Nol-guided opioid administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine opioid managementDrug
Also called Fentanyl
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 Nol-guided opioid administrationDevice
Also called PMD-200 NOL
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: PMD-200 Nol-guided opioid administration |
| 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. Receives: Drug: Routine opioid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 10-minute intervals during the first 30 minutes after extubation.
Secondary outcomes (2)
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.
Measured: 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.
Measured: At 10-minute intervals during the first 30 minutes after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start30 Dec 2020
- Primary completion30 Dec 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt Ruetzler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679818
- Sponsor's protocol ID
- 19-1646
- Status last verified
- May 2024
- First submitted
- 17 Dec 2020
- Last updated
- 21 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36727855
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Consequences of Intraoperative NOL Titration
- ClinicalTrials.gov ID
- NCT04679818
- Acronym / sponsor ID
- 19-1646
- Conditions
- Anesthesia; Adverse Effect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Posted 21 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMD-200 NOL group | Active comparator | Device: PMD-200 Nol-guided opioid administrationClinicians 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 | Drug: Routine opioid managementClinicians will be blinded to PMD-200 Nociception level (NOL) monitoring and use clinical judgement to determine how much fentanyl should be given, and when. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults having major non-cardiac surgery expected to last ≥2 hours
- American Society of Anesthesiologists physical status 1-3
- Age 21-85 years old
- Planned endotracheal intubation
Key exclusion criteria (9 listed)
- Planned neuraxial or regional block
- Clinician preference for an opioid other than, or in addition to, fentanyl
- Non-sinus heart
- Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea
- Lack of English language fluency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine opioid managementAlso: FentanylClinical 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. | Drug | Control Group |
| PMD-200 Nol-guided opioid administrationAlso: PMD-200 NOLPMD-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 | Device | PMD-200 NOL group |
Primary outcome
Pain Scores at 10-minute Intervals for the Initial Hour of Recovery
Time frame: At 10-minute intervals during the first 60 minutes after extubation.
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.
Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery
Time frame: At 10-minute intervals during the first 30 minutes after extubation.
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.
2 secondary outcomes
Number of Measurements With Pain Score Less Than 5 (vs ≥5) for Initial Hour of Recovery
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
Time frame: At 10-minute intervals during the first 30 minutes after extubation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36727855Ruetzler 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Ruetzler, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Routine opioid management and PMD-200 Nol-guided opioid administration in people with Anesthesia; Adverse Effect, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores at 10-minute Intervals for the Initial Hour of Recovery (time frame: At 10-minute intervals during the first 60 minutes after extubation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04679818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.