Methadone vs Magnesium in Spinal Fusion - Full Text View

Purpose

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.

Condition	Intervention	Phase
Idiopathic Scoliosis	Drug: Methadone hydrochloride Drug: Magnesium Sulfate Drug: Remifentanil	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium

Resource links provided by NLM:

MedlinePlus related topics: Scoliosis

Drug Information available for: Methadone Methadone hydrochloride Magnesium Magnesium sulfate Sulfate ion Remifentanil hydrochloride

U.S. FDA Resources

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:

Intra- and Post-operative Pain Relief [ Time Frame: 24 hours post-operatively ] [ Designated as safety issue: No ]
To prospectively compare the effects of intraoperative methadone and magnesium on postoperative opioid requirements, pain scores, narcotic related-side effects and patient and family satisfaction.

Secondary Outcome Measures:

Intra-operative parameters [ Time Frame: Intra-operatively to 24 hours ] [ Designated as safety issue: No ]
To determine the effects of methadone and magnesium on intraoperative parameters including:
1. the inspired concentration of desflurane to maintain a bispectral index of 50-60 (general anesthesia)
2. the dose of remifentanil required to maintain the mean arterial pressure at 50-65 mmHg
3. the need for supplemental agents for blood pressure control despite a maximum remifentanil infusion of 0.3 µg/kg/min
4. the effect of magnesium on the efficacy of neurophysiologic monitoring including SSEP (amplitude and latency) and MEP (mA required to elicit the response post-operative pain scores and opioid requirements for the initial 24 postoperative hours


Estimated Enrollment:	60
Study Start Date:	September 2013
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Remifentanil This arm will receive remifentanil alone as is the current practice.	Drug: Remifentanil
Experimental: Remifentanil plus methadone This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.	Drug: Methadone hydrochloride 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 Other Name: Methadone
Experimental: Remifentanil plus magnesium This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.	Drug: Magnesium Sulfate 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). Other Name: Magnesium

Eligibility


Ages Eligible for Study:	12 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795495

Contacts


Contact: N'Diris Barry, BS, RN, BSN	(614) 355-3467	N'Diris.Barry@NationwideChildrens.org
Contact: Julie Rice, RN, BSN	(614) 355-3142	Julie.Rice@NationwideChildrens.org

Locations


United States, Ohio
Nationwide Children's Hospital	Recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: David P. Martin, MD

Sponsors and Collaborators

Nationwide Children's Hospital

Investigators


Principal Investigator:	David P. Martin, MD	Nationwide Children's Hospital

More Information

Publications:

Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology 2011;115:1153-1161.

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.


Responsible Party:	David P. Martin, Clinical Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:	NCT01795495 History of Changes
Other Study ID Numbers:	IRB13-0036, Active
Study First Received:	February 18, 2013
Last Updated:	February 2, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nationwide Children's Hospital:


Spinal Fusion Scoliosis Methadone	Magnesium Adolescents Back Surgery

Additional relevant MeSH terms:


Methadone Analgesics Magnesium Sulfate Remifentanil Analgesics, Opioid Anesthetics Anesthetics, General Anesthetics, Intravenous Anti-Arrhythmia Agents Anticonvulsants Antitussive Agents Calcium Channel Blockers Cardiovascular Agents Central Nervous System Agents	Central Nervous System Depressants Hypnotics and Sedatives Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Respiratory System Agents Sensory System Agents Therapeutic Uses Tocolytic Agents

ClinicalTrials.gov processed this record on March 03, 2015