CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Methadone hydrochloride +2 moredrug
Likely dose
Methadone hydrochloride 0.1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01795495
NCT01795495Phase 2Completed

Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium

Nationwide Children's Hospital·interventional·Posted Feb 20, 2013·Updated Feb 8, 2018

In Brief

A Phase 2 clinical trial evaluating Methadone hydrochloride, Magnesium Sulfate, and 1 other intervention for Idiopathic Scoliosis. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2013
Enrollment StartSep 1, 2013
Primary CompletionAug 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.4 years ago

Interventions

Methadone hydrochloridedrug

This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia

Magnesium Sulfatedrug

This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).

Remifentanildrug