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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 is a Phase 2 study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 63 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01795495
The ClinicalTrials.gov registry entry for NCT01795495 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Magnesium Sulfate is the first listed.
NCT01795495 reports 0 study locations.
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.
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