Methadone vs Magnesium in Spinal Fusion
|ClinicalTrials.gov Identifier: NCT01795495|
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : February 8, 2018
Last Update Posted : February 8, 2018
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 or disease||Intervention/treatment||Phase|
|Idiopathic Scoliosis||Drug: Methadone hydrochloride Drug: Magnesium Sulfate Drug: Remifentanil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||September 2016|
Active Comparator: Remifentanil
This arm will receive remifentanil alone as is the current practice.
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
- Intra- and Post-operative Pain Relief [ Time Frame: Intra-operative and 24 hours post-operatively ]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.
- Post-operative Pain Scores [ Time Frame: Post-operatively to 24 hours ]VAS pain score - 0 being no pain and 10 being worst pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795495
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||David P. Martin, MD||Nationwide Children's Hospital|