Methadone vs Magnesium in Spinal Fusion
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 12 - 19 |
| Updated: | 2/10/2018 |
| Start Date: | September 2013 |
| End Date: | September 2016 |
Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium
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.
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.
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
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: David P. Martin, MD
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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