A Randomized, Blinded, Prospective Study of the Combined Use of Low-dose Sugammadex Plus Neostigmine Administered for Reversal of Rocuronium-induced Neuromuscular Block in Obese Patients
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 90
- 主要终点
- Incidence of postoperative residual curarization (PORC)
研究概览
简要总结
Reversal of rocuronium-induced neuromuscular block by the combination of low-doses of neostigmine plus sugammadex decreases the cost of anesthetic medications, while maintaining efficacy of reversal in obese patients.
详细描述
Background Neuromuscular paralysis is a frequent requirement to facilitate airway management and surgery. Patients receiving neuromuscular blocking agents (NMBAs) are at risk of residual neuromuscular blockade (RNMB) that can lead to postoperative cardio-pulmonary complications, and may increase postoperative morbidity and mortality.1-2 NMBAs can be antagonized with the cholinesterase inhibitor neostigmine; however, this agent has several undesirable side effects because of its parasympathetic stimulation.3 Thus, muscarinic receptor antagonists, such as atropine, are used along with cholinesterase inhibitors; however, these drugs also have their own set of adverse effects. Despite its relatively slow onset of action and inability to antagonize profound blockade, neostigmine is still used frequently for reversal of rocuronium-induced neuromuscular blockade because of its low cost. Sugammadex is a selective relaxant biding agent, developed to encapsulate the steroidal NMBAs, and proved to be extremely effective for the reversal of either shallow (dose of 2 mg/kg), deep (dose of 4 mg/kg), or even profound (dose of 16 mg/kg) neuromuscular blockade. However, routine use of sugammadex is limited by its relatively high cost compared with neostigmine.
The purpose of the study is to investigate drug costs and adverse effects of low-dose neostigmine (0.025 mg/kg) plus low-dose sugammadex (1 mg/kg) for reversal of rocuronium-induced neuromuscular block, and compare efficacy of antagonism and costs of this combination therapy with the current standard therapies: full-dose sugammadex (2 mg/kg) and full-dose neostigmine (0.05 mg/kg) plus atropine.
Randomization and blinding On randomization, each patient will be allocated by a unique identifying number into study groups "A", "B", or "C". The allocation of a patient to the specific group will be only known by the research assistant. The participating anaesthetists as well as the research staff who collect patient data will remain blinded until after the completion of the study.
For reversal of rocuronium neuromuscular- block we used:
- Group A - Sugammadex (Bridion®) 2 mg/kg,
- Group B - Neostigmine (Miostin®; Stigmosan®) 0.05 mg/kg and atropine 1 mg/ dose.
- Group C - Neostigmine (Miostin®; Stigmosan®) 0.025 mg/kg and atropine 0.5 mg/dose followed within 3 min by Sugammadex 1 mg/kg.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective abdominal surgery
- •16-65 years of age
- •BMI 30-39.9 ( obese class I-II)
- •American Society of Anesthesiologists (ASA) physical status II.
- •Surgery scheduled for general anesthesia and tracheal intubation and planned extubation at the end of surgery
- •Surgical procedures with an anticipated length of at least 60 min.
排除标准
- •Emergency surgery
- •Patients unable to consent to study participation
- •Patients expected to be maintained on mechanical ventilation postoperatively
- •Contraindication to any of the study drugs
- •Patients with existing neuromuscular disease
- •Acute or chronic renal failure (GFR-EPI <30 mL/min/1.73 m2)
- •Acute/chronic liver disease (Child-Pugh Score >1)
- •Hyperkalemia (> 5.3 mmol/l)
- •Pregnancy
- •History of stroke or ongoing paresis
- •Breast feeding
研究组 & 干预措施
neostigmine+atropine
For reversal of rocuronium neuromuscular- block we will use Neostigmine (Miostin®; Stigmosan®) 0.05 mg/kg and atropine 1 mg/ dose.
干预措施: neostigmine+atropine (Drug)
Sugammadex
For reversal of rocuronium neuromuscular- block we will use Sugammadex
干预措施: Sugammadex (Drug)
neostigmine+atropine+sugammadex
For reversal of rocuronium neuromuscular- block we will use Neostigmine (Miostin®; Stigmosan®) 0.025 mg/kg and atropine 0.5 mg/dose followed within 3 min by Sugammadex 1 mg/kg.
干预措施: neostigmine+atropine+sugammadex (Drug)
结局指标
主要结局
Incidence of postoperative residual curarization (PORC)
时间窗: 24 hours
Incidence of postoperative residual curarization (PORC) (defined as a train-of-four ratio, TOFR \<0.9) measured 15 min after administration of the reversal agent.
次要结局
- Time(24 hours)
- Bradycardia(24 hours)
- Residual blockade(24 hours)
研究者
Breazu Caius Mihai
Assistant professor MD,PhD
Iuliu Hatieganu University of Medicine and Pharmacy