Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients, Considering Pain Score, Opioid Consumption, Hemodynamics and Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- opioid consumption
研究概览
简要总结
The study is to evaluate the influence of physostigmine in the postoperative period in intensive care patients considering pain quality, opioid consumption, hemodynamics and mobilisation.
详细描述
Pain management is of major concern in the postoperative period, mostly based on opioids. In numerous experimental and clinical trials cholinergic mechanisms have been demonstrated to play an important antinociceptive role. Physostigmine, a central cholineresterase inhibitor, has been shown to produce analgesia and enhance opiate analgesia after systemic injection. This action is not based on µ-receptor (opioid) activity, but can be mostly explained by stimulation of serotonine (5-HT-3) receptors. The major withdrawal of utilizating physostigmine in postoperative care, is due to its short duration of action.
In the present study, we examined the effect of a continuous intavenous physostigmine application during a patient-controlled analgesia with piritramide for 48 hours compared to a placebo infusion with NaCl.
Major concern was set for consumption of analgesics, VAS-pain scale, hemodynamics, mobilisation and side effects.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Indication for postoperative pain therapy and admission to ICU
- •ASA I-III
- •Weight 50-125 kg
- •Patients that are willing to participate in the present study
排除标准
- •Peridural anesthesia for pain management
- •Severe left ventricular function (EF <30%)
- •Severe/exacerbated COPD; Asthma
- •Chronic renal insufficiency(Creatinine > 1,5 mg/dl)
- •Ulcera ventriculi
- •Known allergy to any of the study agents
- •Hb preoperative <9,5 g/dl
- •Alcohol,drug and/or tablet abuse (Opioids, NSAR)
- •Emergency operation
- •Pregnancy
- •Women of childbearing age and without a negative pregnancy test
- •Severe liver disease (GOT oder GPT > 45 U/L)
- •Severe neurologica derangements (e.g. M. Parkinson, Multiple Sklerosis)
- •History of apoplexia <6 Monate or residua
- •Perioperative myocardial infarction
- •Patients that are not able to agree to the present study
- •Patients that refuse to participate in the present study
- •Patients that are part of any other study
结局指标
主要结局
opioid consumption
时间窗: 48 hours
次要结局
- pain quality (VAS) mobilisation hemodynamics side effects(operation to discharge from hospital)