Methadone vs Magnesium in Spinal Fusion
Information source: Nationwide Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Scoliosis
Intervention: Methadone hydrochloride (Drug); Magnesium Sulfate (Drug); Remifentanil (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Nationwide Children's Hospital Official(s) and/or principal investigator(s):
David P. Martin, MD, Principal Investigator, Affiliation: Nationwide Children's Hospital
Overall contact:
N'Diris Barry, BS, RN, BSN, Phone: (614) 355-3467, Email: N'Diris.Barry@NationwideChildrens.org
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.
Clinical Details
Official title: Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Intra- and Post-operative Pain Relief
Secondary outcome: Intra-operative parameters
Eligibility
Minimum age: 12 Years.
Maximum age: 19 Years.
Gender(s): Both.
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
Locations and Contacts
N'Diris Barry, BS, RN, BSN, Phone: (614) 355-3467, Email: N'Diris.Barry@NationwideChildrens.org
Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting
David P. Martin, MD, Principal Investigator
Additional Information
Related publications: Stemland CJ, Witte J, Colquhoun DA, Durieux ME, Langman LJ, Balireddy R, Thammishetti S, Abel MF, Anderson BJ. The pharmacokinetics of methadone in adolescents undergoing posterior spinal fusion. Paediatr Anaesth. 2013 Jan;23(1):51-7. doi: 10.1111/pan.12021. Epub 2012 Sep 14. Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5. Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24. Elsharnouby NM, Elsharnouby MM. Magnesium sulphate as a technique of hypotensive anaesthesia. Br J Anaesth. 2006 Jun;96(6):727-31. Epub 2006 May 2. Levaux Ch, Bonhomme V, Dewandre PY, Brichant JF, Hans P. Effect of intra-operative magnesium sulphate on pain relief and patient comfort after major lumbar orthopaedic surgery. Anaesthesia. 2003 Feb;58(2):131-5.
Starting date: September 2013
Last updated: May 7, 2015
|
