Pharmacodynamic Trial on Rocuronium in Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Duration of action, defined as: Time to reappearance of T4.
研究概览
简要总结
Aim: To optimize the use of rocuronium (a neuromuscular blocking agent) in obese patients undergoing gastric bypass or gastric banding.
Background: During general anaesthesia, a neuromuscular blocking agent is needed to allow surgery and airway management. Optimal dosing is important in order to avoid inadequately muscle relaxation, but also to avoid overdosage, which can result in prolonged anaesthesia and respiratory complications.
Main hypothesis: Rocuronium dosed according to ideal body weight results in shorter duration of action compared to rocuronium dosed according to corrected body weight without prolonged onset time or compromised airway management or surgical demands for muscle relaxation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •Elective laparoscopic gastric banding or gastric bypass.
排除标准
- •Expected difficult endotracheal intubation based on anatomic or pathologic findings or history.
- •Known or suspected neuromuscular disease, known to affect the neuromuscular blockade.
- •Severely impaired renal or hepatic function, as evaluated by the investigator.
- •Known or suspected allergy to drugs used in the trial.
- •Daily or expected use during the trial of the following drugs, known to affect neuromuscular transmission: Inhalational anaesthetics, magnesiumsalts, clindamycin, polymyxins and aminoglycosides (gentamicin, neomycin, netilmicin, streptomycin og tobramycin).
研究组 & 干预措施
A
Rocuronium dosed after ideal body weight
干预措施: Rocuronium (Drug)
B
Rocuronium dosed after corrected body weight 20%
干预措施: Rocuronium (Drug)
C
Rocuronium dosed after corrected body weight 40%
干预措施: Rocuronium (Drug)
结局指标
主要结局
Duration of action, defined as: Time to reappearance of T4.
时间窗: 1 day
次要结局
- Complete duration of action, defined as: Time to TOF-ratio = 0.9(1 day)
- Onset time(1 day)