The Effect of Intraoperative Esmolol Administration on Postoperative Recovery and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- pain score 24 hours postoperatively
研究概览
简要总结
The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain
详细描述
Contemporary anaesthesiology requires the quest of ways to restrict the use of opioids, which aim at the alleviation of severe postoperative and chronic pain. This is not only due to the side effects involved but also to the epidemic dimensions their use entails. Esmolol, an extremely short-acting cardioselective antagonist of β1 adrenergic receptors, is effectively used in order to attenuate the stress response and minimize undesirable perioperative hemodynamic changes. More specifically, esmolol has been used effectively to reduce pain during induction of anesthesia with propofol and treat tachycardia and hypertension during laryngoscopy. However, recent studies also highlight a possible antinociceptive and/or analgesic effect of esmolol. Therefore, The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •American Society of Anesthesiologists (ASA) classification I-II
- •elective inguinal hernia repair
排除标准
- •body mass index (BMI) >35 kg/m2
- •β-blocker administration preoperatively
- •systematic use of analgesic agents preoperatively
- •chronic pain syndromes preoperatively
- •neurological or psychiatric disease on treatment
- •pregnancy
- •severe hepatic or renal disease
- •history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
- •hemodynamic instability
- •drug or alcohol abuse
- •language or communication barriers
- •lack of informed consent
- •bilateral inguinal hernia repair
研究组 & 干预措施
esmolol group
loading dose of esmolol 0.05 mL/kg and maintenance dose of esmolol 0.3 mL/kg/h
干预措施: Esmolol Hydrochloride (Drug)
placebo group
loading dose of 0.9% sodium chloride 0.05 mL/kg and maintenance dose of 0.9% sodium chloride 0.3 mL/kg/h
干预措施: normal saline (Drug)
结局指标
主要结局
pain score 24 hours postoperatively
时间窗: 24 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 3 hours postoperatively
时间窗: 3 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 6 hours postoperatively
时间窗: 6 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
次要结局
未报告次要终点
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital