Methadone vs Magnesium in Spinal Fusion

Study Overview
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Brief Summary
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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.

Official Title
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Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium

Conditions
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Idiopathic Scoliosis

Intervention / Treatment
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* Drug: Methadone hydrochloride
* Drug: Magnesium Sulfate
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 12, and younger than 19 years of age undergoing posterior spinal fusion for idiopathic scoliosis American Society of Anesthesiologist (ASA) physical status I or II Parents/Guardian willing and able to authorize informed consent Patients willing and able to authorize assent Exclusion Criteria: Patients presenting with neuromuscular scoliosis Patients deemed at increased risk of adverse reactions due to the presence of pre-existing severe organ system dysfunction, including debilitating lung disease, severe obstructive sleep apnea, severe congenital or acquired heart disease, and/or severe renal impairment Patients who are both being currently treated for a psychological disorder and have a history of hospitalization for said disorder

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remifentanil<br>This arm will receive remifentanil alone as is the current practice. | Drug: Remifentanil<br> <br> |
| Experimental: Remifentanil plus methadone<br>This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride. | Drug: Methadone hydrochloride<br>* 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<br>* Other names: Methadone;|
| Experimental: Remifentanil plus magnesium<br>This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate. | Drug: Magnesium Sulfate<br>* 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).<br>* Other names: Magnesium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra- and Post-operative Pain Relief | 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. | Intra-operative and 24 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain Scores | VAS pain score - 0 being no pain and 10 being worst pain. | Post-operatively to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Fusion, Scoliosis, Methadone, Magnesium, Adolescents, Back Surgery