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NCT01795495 · ClinicalTrials.gov registry record · Phase 2
Methadone vs Magnesium in Spinal Fusion
A Phase 2 study, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT01795495: Completed Phase 2 study, sponsored by Nationwide Children's Hospital.
NCT01795495 is a Phase 2 study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01795495, a Phase 2 study, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
Significant pain may occur following posterior spinal fusion despite the use of conventionally accepted techniques including patient controlled analgesia. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects. The current study would use a prospective, randomized trial investigating the efficacy of one of 2 regimens as adjuncts to intraoperative anesthesia and postoperative analgesia, along with a third control group. The patients would be randomized to receive remifentanil plus a single intraoperative dose of methadone; remifentanil plus a bolus followed by an infusion of magnesium; or remifentanil alone. In addition, the two medications being studied might make it easier to determine the efficacy of neurophysiologic monitoring including somatosensory evoked potential (SSEP) (amplitude and latency) and motor evoked potential (MEP) (mA) required to elicit the response. The purpose of this study would be to explore the effects of intraoperative methadone vs magnesium on intraoperative anesthetic requirements, postoperative opioid requirements, the efficacy of neurophysiologic monitoring including SSEP and MEP, inspired concentration of desflurane, remifentanil, and the need for intraoperative supplemental agents to control blood pressure.
Primary Outcome
To prospectively compare the effects of intra-operative methadone and magnesium on postoperative opioid requirements. Total amount of hydromorphone administered in OR, recovery room (PACU), and on the inpatient ward 24 hours post-operatively.
Interventions
- DRUG Magnesium Sulfate
- DRUG Methadone hydrochloride
- DRUG Remifentanil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
What the finished NCT01795495 record still lists
NCT01795495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Magnesium Sulfate is the first listed.
NCT01795495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01795495 about?
NCT01795495 is a clinical study titled "Methadone vs Magnesium in Spinal Fusion". Significant pain may occur following posterior spinal fusion despite the use of conventionally accepted techniques including patient controlled analgesia. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects. The cur...
What is the current status of trial NCT01795495?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2013-09. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01795495?
The interventions under investigation include: Magnesium Sulfate (DRUG), Methadone hydrochloride (DRUG), Remifentanil (DRUG).
Who is sponsoring clinical trial NCT01795495?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01795495's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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