NCT03218306Unknown不适用
Surgical Pleth Index Guided Intraoperative Analgesia Versus Standard Clinical Approach During Desflurane Based General Anesthesia for Thyroidectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Remifentanil consumption
研究概览
简要总结
The study is aimed at confronting a surgical pleth index based protocol for intraoperative analgesia in a desflurane based general anesthesia for thyroidectomy, versus a standard clinical approach. A reduction in analgesic consumption and improvement in hemodynamics are expected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •18<age<80 years
- •American society of anesthesiology (ASA) physical status I -II
- •6 hrs fasting
排除标准
- •Arrhythmia or Pacemaker
- •Central or peripheral nervous system or muscular disease
- •Drugs active on autonomous nervous system (eg clonidine)
- •Obesity (BMI >35)
- •Chronic Pain
- •Addictions or central nervous acting drugs use
- •Hypertension (if not treated)
- •Connective tissue disease
- •Pregnancy
- •Allergy or hypersensitivity to study drugs
- •QT prolongation
- •Absence of inclusion criteria
研究组 & 干预措施
SPI guided analgesia
Experimental
SPI ≤ 10 percentual points over the post-induction/pre-surgical incision value
干预措施: Surgical Pleth Index (Device)
Clinical Guided Analgesia
Active Comparator
No SPI guidance
干预措施: Clinical guidance (Other)
结局指标
主要结局
Remifentanil consumption
时间窗: Intraoperative
Cumulative remifentanil consumption throughout surgery
次要结局
- Hemodynamics(intraoperative)
- Desflurane(intraoperative)
- Extubation delay(intraoperative)
- Post-operative analgesia 1(24 hr post operative)
- Post-operative analgesia 2(24 hr post operative)
- Adverse reactions(24 hr post operative)
- Patient satisfaction(24 hr post operative)
研究者
Prof. Gabriele Finco
Professor of Anesthesiology and Intensive Care
University of Cagliari
研究点 (2)
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