Methadone vs Magnesium in Spinal Fusion

Nationwide Children's Hospital

Status and phase: Completed; Phase 2

Conditions: Idiopathic Scoliosis

Treatments: Drug: Remifentanil; Drug: Magnesium Sulfate; Drug: Methadone hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01795495

IRB13-0036

Active (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 3 patient groups

Remifentanil

Active Comparator group

Description:

This arm will receive remifentanil alone as is the current practice.

Treatment:

Drug: Remifentanil

Remifentanil plus methadone

Experimental group

Description:

This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.

Treatment:

Drug: Methadone hydrochloride

Remifentanil plus magnesium

Experimental group

Description:

This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.

Treatment:

Drug: Magnesium Sulfate