Effect of Neuromuscular Blockade Reversal With Sugammadex on Oxygenation, Pain and Arousal States in the Post Anesthesia Care Unit
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean Lowest Saturation
研究概览
简要总结
Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. The investigators hyposthesise that reversal with sugammadex leads to favorable postoperative respiratory conditions and less pain compared to reversal with neostigmine.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years
- •- BMI < 35
- •-ASA class I- III
- •-Patients scheduled for surgery requiring general anesthesia with the use of NMBA's
- •Patients with ability to give oral and written informed consent
排除标准
- •Failure to meet the inclusion criteria
- •-Known or suspected neuromuscular disorders impairing neuromuscular function
- •-Allergies to muscle relaxants, anesthetics or narcotics
- •A (family) history of malignant hyperthermia
- •-Women who are or may be pregnant or are currently breast feeding
- •-Contraindications for the use of neostigmine
- •Intestinal obstruction,
- •COPD GOLD 4
- •-Abnormal heart rhythm (eg. bradycardia: < 40/min);
- •-Surgery requiring neuraxial anesthesia / analgesia
- •-Preoperative cognitive dysfunction or mental disabilities
- •-Preexistent significant pulmonary disease with preoperative SpO2 < 90%
- •-Preoperative ICU treatment / intubation (ICU patient);
- •-Need for postoperative ICU treatment or ventilation;
研究组 & 干预措施
Sugammadex
Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
干预措施: Sugammadex (Drug)
neostigmine
subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
干预措施: Neostigmine (Drug)
结局指标
主要结局
Mean Lowest Saturation
时间窗: 45 minutes post surgery
Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery
次要结局
- Sedation(45 minutes post surgery)
- Pain(45 minutes post surgery)
研究者
Albert Dahan
Prof. Dr. A. Dahan
Leiden University Medical Center