Methadone vs Magnesium in Spinal Fusion
Condition: Idiopathic Scoliosis
MeSH terms: Scoliosis
Intervention: Methadone hydrochloride; Magnesium Sulfate; Remifentanil
Intervention description: 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; 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).
Intervention MeSH terms: Magnesium Sulfate; Remifentanil; Methadone
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 12 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Spinal Fusion; Scoliosis; Methadone; Magnesium; Adolescents; Back Surgery

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.
    

Eligibility criteria:

        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