Dosing of Methadone for Spine Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in opioid requirement for complex spine surgery patients
研究概览
简要总结
This study compares two methods of dosing methadone for complex spine cases
详细描述
Patients with spine surgery experience a significant amount of pain that can interfere with healing, rehabilitation and contribute to morbidity in the post-operative period. This study will compare post-operative opioid requirement at 24 and 48 hours to determine if methadone given in small aliquots until respiratory depression can act as a self-control to determine the correct dose required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Post-operative data will be collected by blinded staff. Patient daily pain based on the analog scale of 0-10 post-operative for the first 72 hours, total opioid usage, length of stay, time to get out of bed.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures.
- •At or between the ages 18 to 75 years.
- •Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.
排除标准
- •Methadone or buprenorphine use.
- •Morbid obesity with BMI>40 Kg/m
- •Chronic renal failure with creatinine>2.0 mg/dL.
- •Liver failure as determined by cirrhosis or history of fulminant hepatic failure.
- •Current or historical alcohol abuse.
- •Current or historical drug abuse.
- •Patients with history of prolonged QTc, as defined as a QTc value >450 ms in males and >460 ms in females.
- •Patients with ASA status IV or V.
- •Surgical diagnosis including spine tumor, infection, or trauma.
- •In the Principal Investigator's opinion is not a candidate for the study.
- •Unwilling to sign the informed consent form.
研究组 & 干预措施
Standard dosing of methadone
Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
干预措施: Standard dosing of methadone (Drug)
Aliquots of methadone titrated to apnea
Receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed.
干预措施: Aliquots of methadone titrated to apnea (Drug)
结局指标
主要结局
Change in opioid requirement for complex spine surgery patients
时间窗: Changes from baseline (pre-op) up to 72 hours post-op
Titrating methadone to respiratory depression allows the patient to act as his own control determining the dose he will require, improving pain control and consequently decreasing side effects and complications.
次要结局
未报告次要终点