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NCT04305015 · ClinicalTrials.gov registry record · NA
Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration - Pilot
A NA study of Nociceptive Pain, sponsored by Medasense Biometrics.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT04305015: Completed NA study of Nociceptive Pain, sponsored by Medasense Biometrics.
NCT04305015 is a NA study of Nociceptive Pain that has completed, run by Medasense Biometrics. The registered enrollment target is 26 participants, below the 218-participant average among 3 other Nociceptive Pain trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04305015, a NA study of Nociceptive Pain, has completed, sponsored by Medasense Biometrics.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE NOL Guided Analgesia
- OTHER Routine opioid management
Study Locations (1)
Ohio
- Cleveland clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2020-12-30 |
| Phase | NA |
What the finished NCT04305015 record still lists
NCT04305015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 218-participant average among 3 other Nociceptive Pain trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Nociceptive Pain appearing as the primary indexed condition, and to 2 interventions - of which NOL Guided Analgesia is the first listed.
NCT04305015 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04305015 about?
NCT04305015 is a clinical study titled "Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration - Pilot". 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 pres...
What is the current status of trial NCT04305015?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2020-11-09. Estimated completion is 2020-12-30.
What conditions does trial NCT04305015 study?
This clinical trial studies the following conditions: Nociceptive Pain.
What interventions are being tested in trial NCT04305015?
The interventions under investigation include: NOL Guided Analgesia (DEVICE), Routine opioid management (OTHER).
Who is sponsoring clinical trial NCT04305015?
This trial is sponsored by Medasense Biometrics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04305015 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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