Methadone vs Magnesium in Spinal Fusion

NCT01795495 | Completed Phase 2 Results DMC

• 2 other identifiers: IRB13-0036Active
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Scoliosis

Keywords

Spinal Fusion; Scoliosis; Methadone; Magnesium; Adolescents; Back Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-operative Pain Scores

  Post-operatively to 24 hours

Study Arms (3)

Remifentanil

ACTIVE COMPARATOR

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

Drug: Remifentanil

Remifentanil plus methadone

EXPERIMENTAL

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

Drug: Methadone hydrochloride

Remifentanil plus magnesium

EXPERIMENTAL

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

Drug: Magnesium Sulfate

Interventions

Methadone hydrochloride DRUG

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

Also known as: Methadone

Remifentanil plus methadone

Magnesium Sulfate DRUG

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).

Also known as: Magnesium

Remifentanil plus magnesium

Remifentanil DRUG

Remifentanil

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (6)

• 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.

  PMID: 22978825 BACKGROUND

• 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.

  PMID: 22037641 BACKGROUND

• 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.

  PMID: 20418538 BACKGROUND

• Elsharnouby NM, Elsharnouby MM. Magnesium sulphate as a technique of hypotensive anaesthesia. Br J Anaesth. 2006 Jun;96(6):727-31. doi: 10.1093/bja/ael085. Epub 2006 May 2.

  PMID: 16670112 BACKGROUND

• 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. doi: 10.1046/j.1365-2044.2003.02999.x.

  PMID: 12562408 BACKGROUND

• Martin DP, Samora WP 3rd, Beebe AC, Klamar J, Gill L, Bhalla T, Veneziano G, Thung A, Tumin D, Barry N, Rice J, Tobias JD. Analgesic effects of methadone and magnesium following posterior spinal fusion for idiopathic scoliosis in adolescents: a randomized controlled trial. J Anesth. 2018 Oct;32(5):702-708. doi: 10.1007/s00540-018-2541-5. Epub 2018 Aug 4.

  PMID: 30078167 DERIVED

MeSH Terms

Conditions

Scoliosis

Interventions

Methadone; Magnesium Sulfate; Magnesium; Remifentanil

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: David Martin, MD
• Organization: Nationwide Children's Hospital

David.Martin@nationwidechildrens.org

6147224200

Study Officials

• David P. Martin, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 8, 2018
• Results First Posted: February 8, 2018

Record last verified: 2018-02

Locations

US (1)