Idiopathic Scoliosis
Conditions
Keywords
Spinal Fusion, Scoliosis, Methadone, Magnesium, Adolescents, Back Surgery
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.
Interventions
DRUGRemifentanil
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
DRUGMagnesium 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).
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra- and Post-operative Pain Relief | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Scores | Post-operatively to 24 hours | VAS pain score - 0 being no pain and 10 being worst pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remifentanil This arm will receive remifentanil alone as is the current practice.
Remifentanil | 20 |
| Remifentanil Plus Methadone This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.
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 | 22 |
| Remifentanil Plus Magnesium This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.
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). | 21 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Remifentanil | Remifentanil Plus Methadone | Remifentanil Plus Magnesium | Total |
|---|---|---|---|---|
| Age, Continuous | 14.2 years STANDARD_DEVIATION 1.4 | 15.4 years STANDARD_DEVIATION 1.2 | 15.3 years STANDARD_DEVIATION 1.9 | 15.0 years STANDARD_DEVIATION 1.6 |
| BMI (kg/m2) | 21.6 kg/m^2 STANDARD_DEVIATION 4.3 | 22.8 kg/m^2 STANDARD_DEVIATION 5.7 | 24.2 kg/m^2 STANDARD_DEVIATION 5.6 | 22.6 kg/m^2 STANDARD_DEVIATION 5.3 |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 18 Participants | 52 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 22 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Intra-operative and 24 hours post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remifentanil | Intra- and Post-operative Pain Relief | 0.34 mg/kg | Standard Deviation 0.11 |
| Remifentanil Plus Methadone | Intra- and Post-operative Pain Relief | 0.26 mg/kg | Standard Deviation 0.1 |
| Remifentanil Plus Magnesium | Intra- and Post-operative Pain Relief | 0.38 mg/kg | Standard Deviation 0.1 |
Secondary
Post-operative Pain Scores
VAS pain score - 0 being no pain and 10 being worst pain.
Time frame: Post-operatively to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remifentanil | Post-operative Pain Scores | 4.6 units on a scale | Standard Deviation 2.2 |
| Remifentanil Plus Methadone | Post-operative Pain Scores | 5.1 units on a scale | Standard Deviation 1.8 |
| Remifentanil Plus Magnesium | Post-operative Pain Scores | 5.1 units on a scale | Standard Deviation 1.2 |