Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in TOF(train of four) recovered to 0.7 and 0.9 from the last injection
研究概览
简要总结
To observe the pharmacodynamics of intravenous injection of cisatracurium to maintain deep neuromuscular blockade in obese patients with lean body mass in laparoscopic colorectal surgery
详细描述
According to the random number table method, one hundred and twenty patients who underwent elective laparoscopic colorectal surgery were divided into four groups (n=30): Normal weight patients according to lean body weight group(NL group), normal weight patients according to real weight group (NR group), obese patients according to lean body weight group(OL group), and obese patients according to real weight group(OR group).Intraoperative deep neuromuscular blockade (PTC≤2)was maintained in all four groups.The dosage of cisatracurium, the number of injections,time to effect,time to recovery from TOFr,time to recover TOFr（train-of-four rate） to 0.7 and 0.9,and time to stay in PCAU were recorded.The surgeon's satisfaction with the operative field and the average intraoperative pneumoperitoneum pressure were recorded at the time of pneumoperitoneum establishment,1 hour and 2 hours after pneumoperitoneum establishment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- 是
入选标准
- •Laparoscopic Colorectal Surgery
- •American Society of Anesthesiologists (ASA) grades I-III
排除标准
- •Patients with heart, lung and other vital organ disorders
- •Preoperative fluid and electrolyte disturbance
- •Preoperative water and electrolyte disorders have a history of neuromuscular disease or take medications that have an impact on neuromuscular function
- •There is a significant airway difficulty
- •Refuse to sign informed consent
结局指标
主要结局
Change in TOF(train of four) recovered to 0.7 and 0.9 from the last injection
时间窗: up to 1 hour after the surgery
The recovery of TOF(train of four) was continue observed after surgery.Recording the time both when TOF(train of four) recovered to 0.7 and 0.9
Change in average dosing interval time
时间窗: during the surgery
PTC(post-tetanic count)was measured every 6min during the operation, and cisatracurium was injected once when PTC \> 2,average dosing interval time was recorded
Change in Times of adding cisatracurium
时间窗: during the surgery
PTC was measured every 6min during the operation, and cisatracurium was injected once when PTC \> 2,and recording the total times of injection.
Change in time of onset
时间窗: through study completion, an average of 3 minute after induction
0.15mg/kg (3ED95) cisatracurium was given to all groups according to actual body weight as induction dose. Tracheal intubation was performed in all groups when TOFr(train of four ratio)=0.recording the time during this process.
Change in total dosage of cisatracurium
时间窗: during the surgery
PTC(post-tetanic count) was measured every 6min during the operation, and cisatracurium was injected once when PTC \> 2,and recording the total dosage of total dosage of cisatracurium
Change in time during PACU(postanesthesia care unit)
时间窗: up to 2 hour after the surgery
recoding the duration of stay in PACU(postanesthesia care unit)
surgical rating scale(SRS)
时间窗: during the surgery
Surgical rating Scale (SRS) was evaluated by surgical surgeons at the beginning, 1h and 2h of surgery, with a range of 1 to 5, corresponding to "extremely poor", "poor", "adequate", "good" and "best".
次要结局
- Incidence of postoperative pain(Immediately after surgery and One day after surgery)
- Whether hypoxemia occurs after extubation(within 10 minutes after extubation)
- Change in PaCO2 before and after pneumoperitoneum(before and after pneumoperitoneum during the surgery)
- The change of MAP (mean arterial pressure)(immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection)
- The change of HR(heart rate)(immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection)