A Preoperative Methadone Single Dose for Moderately to Severely Painful Surgery Reduces Postoperative Morphine Consumption Results From a Double-blind Pragmatic Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Difference of postoperative morphine consumption
研究概览
简要总结
The aim of this study was to evaluate the effect of intraoperative methadone on postoperative analgesic requirements, pain scores and patient satisfaction in comparison to standard intraoperative pain control with fentanyl.
详细描述
Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia. Patients were randomized to receive either a single shot of methadone (0.2mg/kg) or fentanyl (0.003mg/kg) for induction of anesthesia. In cases of insufficient intraoperative analgesia repeated fentanyl administration was possible. Postoperative analgesia was provided with patient controlled morphine in both groups (PCA = Patient Controlled Analgesia). Pain was assessed using the numerical rating scale (NRS) at rest and after coughing, at 15 minutes post extubation, and repeated every 6 hours up to 72 hours postoperatively. The levels of sedation and nausea/vomiting were also evaluated in parallel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •informed consent
- •Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia.
- •german speaking patients
排除标准
- •patients including other studies
- •breast feeding
- •patients in methadone substitution therapy
- •dependent drug user
- •patients with BMI greater than 36kg/m2
- •patients with chronic or acute renal failure with serum creatinine greater than 400µmol/L
- •patients with liver insufficiency or failure
- •alcoholics
- •patients with acute heard attack
研究组 & 干预措施
methadone group
Drug: methadone methadone group 0.2mg/kg to start surgery TIVA: general anesthesia will be based on Fentanyl an Propofol, titrated to achieve bispectral index (BIS) between 40-60.
干预措施: Methadone (Drug)
结局指标
主要结局
Difference of postoperative morphine consumption
时间窗: first 48 hours postoperatively
Difference in milligrams of morphine used as rescue by patient controlled analgesia pump
次要结局
- Difference in pain scores, using the Numeric Rating Scale(first 72 hours postoperatively)
研究者
Philipp Bühler, MD
MD
Kantonsspital Baden