EUCTR2021-002625-20-BE进行中（未招募）1 期
Intrathecal morphine administration for minimally invasive pancreatic surgery: A double blind, prospective randomized placebo-controlled trial. - IT morphine for MIPS
niversity Hospitals Leuven0 个研究点目标入组 128 人开始时间: 2021年6月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 18-80 years of age
- •-BMI = 40 kg/m2
- •-Patient is able to give informed consent
- •-Patient understands the use of morphine PCIA
- •-Patient is scheduled for elective minimally invasive pancreatic surgery
- •-ASA I-IV
- •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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •- Refusal to participate in the trial
- •-Inability to operate a PCIA system
- •-Chronic opioid use, or chronic pain patient
- •-Obstructive sleep apnea syndrome (OSAS) requiring CPAP therapy
- •-If patient is known with kidney disease or renal dysfunction, the GFR will be checked and patient will be excluded if GFR < 30 mL/min.
- •-Neuraxial anesthesia will only be performed with normal clotting lab results (UZ Leuven):
- •-Thrombocytes = 80 x 109/L
- •-INR = 1,5
- •-aPTT (s) = 31
- •-Presence of contra-indications for spinal anesthesia (patients on anticoagulants, coagulation deficits, severe spinal canal stenosis, neurological deficits, increased intracranial pressure, severe aortic stenosis as defined by aortic valve area (AVA) < 1 cm2)
- •-Presence of contra-indications for intrathecal medication (pre-operative respiratory oxygen need, sleep apnea disorder, diamorphine/morphine allergy, local anesthetic allergy)
研究者
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