跳至主要内容
临床试验/NCT06056245
NCT06056245招募中不适用

Postoperative Pharmacokinetics of Methadone in Patients With Chronic Kidney Disease

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Plasma concentration

研究概览

简要总结

The goal of this observational study is to describe the influence of renal function on the pharmacokinetics of methadone used through an intravenous patient-controlled analgesia (IV-PCA) pump for the management of acute postoperative pain. After surgery the participants will use an IV-PCA of methadone and blood samples will be withdrawn to measure the plasmatic levels of it.

The main question the study aims to answer is:

• Is the pharmacokinetic of methadone used in an IV-PCA pump impaired in patients with chronic kidney disease?

详细描述

This study will be carried out at the Pontifical Catholic University of Chile Hospital with prior approval by the ethics committee. Study staff will assess the inclusion criteria, obtain informed consent, withdraw the blood samples, and record and manage the data.

Patients will be recruited before surgery. At the time the patient agrees to participate in the study, the functioning and adequate use of an intravenous patient-controlled analgesia (IV-PCA) pump will be explained by one of the members of the research team. The anesthetic, surgical, or postoperative care will not be affected by this research study.

Once the patient is in the theatre, standard intraoperative monitoring will be applied, including pulse oximetry, electrocardiography, automatic blood pressure cuff, capnography, and bispectral index monitoring (BIS system). The induction of anesthesia will be performed by the administration of remifentanil in a target-controlled infusion (TCI) using the MINTO model, propofol 1-2mg/kg and atracurium 0.5mg/kg or rocuronium 0.6mg/kg.

After induction, a second intravenous line will be installed in the contralateral arm exclusively to obtain blood samples. Subsequently, based on the ideal body weight, patients will receive a bolus of 0.1mg/kg of methadone at the beginning of surgery with a maximum dose of 20mg.

The maintenance of general anesthesia will be through the administration of sevoflurane to achieve BIS values between 40-60. Atracurium or rocuronium in doses of 5-10mg will be administered according to the neuromuscular block monitor and the infusion of remifentanil will be at the discretion of the anesthesiologist in charge to achieve mean arterial pressure within 20% of the baseline measure (previous induction of anesthesia). Episodes of hypotension will be treated with phenylephrine 50-100 mcg, ephedrine 6-12mg, or fluid bolus, as indicated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with chronic kidney disease (CrCl 15-60 ml/min)
  • Patients over 18 years old undergoing surgery requiring general anesthesia with subsequent use of intravenous methadone patient-controlled analgesia
  • Hospital stay ≥ 48 hours
  • Body mass index 18-35 kg/m2

排除标准

  • History of liver disease
  • Need for dialysis (hemo or peritoneal dialysis)
  • Use of home oxygen therapy
  • American Society of Anesthesiologists (ASA) physical status IV-V
  • Pregnancy
  • Chronic opioid use
  • Methadone allergy
  • Prolonged QT interval
  • Use of antiarrhythmics that prolong the QT interval
  • Inability to understand the proper use of PCA

研究组 & 干预措施

Study group

Patients with chronic kidney disease (CKD) over 18 years old undergoing surgery using general anesthesia with subsequent use of intravenous patient-controlled analgesia (IV-PCA) of methadone.

干预措施: Preoperative step (Procedure)

Study group

Patients with chronic kidney disease (CKD) over 18 years old undergoing surgery using general anesthesia with subsequent use of intravenous patient-controlled analgesia (IV-PCA) of methadone.

干预措施: Intraoperative (Drug)

Study group

Patients with chronic kidney disease (CKD) over 18 years old undergoing surgery using general anesthesia with subsequent use of intravenous patient-controlled analgesia (IV-PCA) of methadone.

干预措施: Post-operative (Drug)

结局指标

主要结局

Plasma concentration

时间窗: 5, 15, 30, 60 minutes and 2, 4, 6, 9, 12, 24, 36 and 72 hours after the intraoperative bolus of methadone

Blood samples will be taken, collected in heparin tubes, and centrifuged. The extracted serum will be placed in cryotubes that will be stored at -80 °C until analysis. Methadone samples will be analyzed using a high performance liquid chromatography (HPLC) spectrofluorometric method. Lower limits of quantification (LLOQ) will be determined and samples below the LLOQ will not be included in the analysis.

次要结局

  • Total use of methadone(2, 4, 6, 9, 12, 24, 36 and 48 hours after the intraoperative bolus of methadone)
  • Post-operative Pain(2, 4, 6, 9, 12, 24, 36 and 48 hours after the intraoperative bolus of methadone)
  • Respiratory depression(2, 4, 6, 9, 12, 24, 36 and 48 hours after the intraoperative bolus of methadone)
  • Hypoxemia(2, 4, 6, 9, 12, 24, 36 and 48 hours after the intraoperative bolus of methadone)
  • Sedation(2, 4, 6, 9, 12, 24, 36 and 48 hours after the intraoperative bolus of methadone)
  • Nausea or vomiting(2, 4, 6, 9, 12, 24, 36 and 48 hours after the intraoperative bolus of methadone)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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