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临床试验/EUCTR2023-000172-36-BE
EUCTR2023-000172-36-BE招募中1 期

Intraoperative methadone for the prevention of postoperative pain: a randomized, double-blind clinical study in orthopedic surgery.

CHU Brugmann0 个研究点目标入组 80 人开始时间: 2023年1月30日最近更新:
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
CHU Brugmann
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Age between 18 and 80 years old
  • ASA 1-3 status
  • Elective partial or total hip and knee arthroplasty
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 55
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 25

排除标准

  • Patient refusal
  • Preoperative renal failure (serum creatinine > 2 mg/dL or 1.5-fold increase in basal plasma creatinine or GFR < 50 ml/min/1.73m2)
  • Significant hepatic dysfunction (PT <50% or increase in 3 times basal transaminases)
  • Known heart failure
  • Preoperative hemodynamic instability (preoperative use of inotropes or vasopressors)
  • Known methadone or sufentanil allergy
  • Preoperative opioid use or history of opioid abuse
  • Pregnancy and breastfeeding
  • Treatment with beta blockers and HR < 60 bpm
  • Treatment with antidepressants

研究者

发起方
CHU Brugmann

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