NCT01125059撤回不适用
The Effect of Methadone on Perioperative Analgesia After Posterior Lumbar Fusion - A Randomized, Placebo-controlled, Double-blinded Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hydromorphone postoperative opioid consumption (POC) at 48 hours
研究概览
简要总结
What is the influence of methadone on postoperative analgesia after lumbar interbody fusion in opioid naïve patients or patients who are taking less than equivalent of 15 mg IV morphine each day? What is the incidence of opioid related postoperative side effects after the administration of methadone in the operating room?
详细描述
Hypothesis
- We hypothesize that 0.2 mg/kg of methadone will result in decreased postoperative hydromorphone consumption compared to hydromorphone alone in opioid naïve patients or patients who are taking less than the equivalent of 15 mg IV morphine a day undergoing lumbar interbody fusion.
- We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •ASA physical status I, II, and III, male and non-pregnant female
- •English-speaking patients
- •Ages 18-75 years
- •Undergoing elective one or two level posterior lumbar interbody fusion
排除标准
- •Use of more than the equivalent of 15 mg of IV morphine/24 hr in the past 2 weeks.
- •Use of drugs within the past 6 months that effect the pharmacokinetics or pharmacodynamics of opioids (i.e., benzodiazepines, anti-retroviral agents, rifampin, ketoconazole, erythromycin, or phenytoin).
- •history of substance abuse at any time in the past
- •known QT prolongation
- •Non-elective operations (i.e., cancer or trauma)
- •severe hepatic impairment (serum albumin < 3.0 g/dL in the presence of a history of liver disease)
- •pregnancy
- •inability to operate a patient-controlled analgesia device
研究组 & 干预措施
Methadone Group
Active Comparator
0.2 mg/kg IV methadone
干预措施: Methadone (Drug)
Placebo Group
Placebo Comparator
5 mL saline bolus
干预措施: Saline (Drug)
结局指标
主要结局
Hydromorphone postoperative opioid consumption (POC) at 48 hours
时间窗: 48 hrs
PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU
次要结局
- pain at rest and with movement (numerical Rating Scale, NRS)(1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs)
- number of occurrences of nausea (resulting in treatment)(1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs)
- recorded emesis(1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs)
- occurrence of pruritus(1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs)
- the level of sedation (modified Observer's Assessment of Alertness and Sedation Scale, modified OAA/S scale)(1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs)
- Hydromorphone postoperative opioid consumption (POC)(1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs)
- Intraoperative remifentanil consumption(the 8 hours prior to arrival in the recovery room)
- the number of occurrences of ventilatory depression during each evaluation interval(1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs)
研究者
Dhanesh Gupta
Associate Professor of Anesthesiology & Neurological Surgery
Northwestern University
研究点 (1)
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