Clinical Effectiveness and Safety of Intraoperative Methadone in Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Opioid consumption (morphine mg equivalents)
研究概览
简要总结
The role of a single-dose intraoperative methadone on postoperative pain and opioid consumption in patients undergoing Surgeon Accuracy Robot Assistant cystectomy. A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing robotassisted cystectomy.
详细描述
During early recovery after surgery, intravenous opioids are typically administered to control the pain, either as intermittent bolus administration by nursing staff or by a patient-controlled analgesia device. Unfortunately, repeated doses or boluses of shorter-acting opioids, such as morphine, oxycodone and fentanyl, result in fluctuating blood concentrations, with the inherent risk of only relatively brief periods of adequate pain relief. Moreover, the use of shorter-acting opioids increases the risk of opioid-associated side effects, such as sedation, nausea and vomiting. An alternative approach to the postoperative use of shorter-acting opioids is therefore called for.
In this respect, methadone is an opioid with unique pharmalogical properties that may be advantageous when applied intraoperatively. A single-dose of this long acting opioid could provide a stable analgesia and potentially reduce the need for shorter-acting opioids
Method:
110 patients will be included in an investigator-initiated, prospective, randomised, double-blind, controlled trial with two arms: intervention arm (methadone 0.15 mg/kg ideal body weight). Control arm (morphine 0.15 mg/kg ideal body weight). The study will be GCP-monitored, and is approved by the Danish Health and Medicines Authority (2020041652) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-275-19).
Hypothesis We hypothesize that a single-dose of intravenous intraoperative methadone is efficient and safe for the treatment of postoperative pain after cystectomy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization and medication will be handled by hospital pharmacy. Randomisation list will be concealed until all statistical analyses are made.
- plan for data analysis was decided upon at a meeting with a statistician on September 7th, 2023. The plan was made before A and B lists were obtained from the hospital pharmacy. This study will be undertaken as an equivalence trial with the application of intention to treat analysis. Missing data are assumed to be missing at random. Primary outcome will be analyzed paired or unpaired t-test for difference, depending on distribution. Analysis of secondary outcome NRS will be reported as median(interquartile range) and compared between groups at the various times using the Mann-Whitney U test. If normal distributed multilevel mixed effects linear regression will be carried out. Analysis of other secondary outcomes will be dichotomized and presented for 3 and 24 hours with X2 test.
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (≥18 years) scheduled for elective robot assisted cystectomy.
排除标准
- •American Society of Anesthesiologists (ASA) physical status IV or V
- •Prolonged QTc-interval assessed by electrocardiogram (> 440 milliseconds)
- •Existing treatment with a high risk of QTc-interval prolongation
- •Allergy to study drugs
- •Preoperative daily use of opioids
- •Inability to provide informed consent
- •Severe respiratory insufficiency (oxygen treatment at home)
- •Heart failure (ejection fraction < 30%)
- •Acute abdominal pain
- •Signs of severe liver dysfunction (cirrhosis, inflammation/hepatitis or liver malignancy)
- •Severe kidney insufficiency (estimated Glomerular Filtration Rate < 30 ml/min)
- •Treatment with rifampicin
- •Phaeochromocytoma
- •Treatment with MAO-inhibitor during the last 14 days
- •Pregnancy
- •Nursing mothers
- •Intraoperative conversion to open surgery (secondary inclusion criterion)
- •Epidural analgesia in relation to surgical procedure
研究组 & 干预措施
Methadone
A 10 ml syringe with 2 mg/ml of methadone will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation.
干预措施: Methadone (Drug)
Morphine
A 10 ml syringe with 2 mg/ml of morphine will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation.
干预措施: Morphine (Drug)
结局指标
主要结局
Opioid consumption (morphine mg equivalents)
时间窗: 24 hours
• Opioid consumption within the first 24 hours after extubation
次要结局
- Pain intensity(within 24 hours)
- Opioid consumption (morphine mg equivalents)(72 hours)
- PONV(Within 24 hours)
- Level of sedation(3 hours)
- Adverse events(6 hours)
- Patient satisfaction from 0-10.(24 hours)
- Discharge(6 days)