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 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.
|Idiopathic Scoliosis||Drug: Methadone hydrochloride Drug: Magnesium Sulfate Drug: Remifentanil||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium|
- Intra- and Post-operative Pain Relief [ Time Frame: 24 hours post-operatively ]To prospectively compare the effects of intraoperative methadone and magnesium on postoperative opioid requirements, pain scores, narcotic related-side effects and patient and family satisfaction.
- Intra-operative parameters [ Time Frame: Intra-operatively to 24 hours ]
To determine the effects of methadone and magnesium on intraoperative parameters including:
- the inspired concentration of desflurane to maintain a bispectral index of 50-60 (general anesthesia)
- the dose of remifentanil required to maintain the mean arterial pressure at 50-65 mmHg
- the need for supplemental agents for blood pressure control despite a maximum remifentanil infusion of 0.3 µg/kg/min
- the effect of magnesium on the efficacy of neurophysiologic monitoring including SSEP (amplitude and latency) and MEP (mA required to elicit the response post-operative pain scores and opioid requirements for the initial 24 postoperative hours
|Study Start Date:||September 2013|
|Study Completion Date:||September 2016|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Remifentanil
This arm will receive remifentanil alone as is the current practice.
Experimental: Remifentanil plus methadone
This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.
Drug: Methadone hydrochloride
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
Other Name: Methadone
Experimental: Remifentanil plus magnesium
This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.
Drug: Magnesium Sulfate
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).
Other Name: Magnesium
Please refer to this study by its ClinicalTrials.gov identifier: NCT01795495
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||David P. Martin, MD||Nationwide Children's Hospital|