To Observe Mivacurium Chloramine Muscle Relaxation Effect in the Operation Anesthesia Patients With Liver Cirrhosis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- TOF ratio
研究概览
简要总结
Observed the muscle relaxation of mivacurium in patients with liver cirrhosis.Clear of mivacurium in patients with liver cirrhosis without muscle relaxant accumulation and delayed recovery phenomenon
详细描述
The liver is an important organ of the body to maintain life activities, material and energy metabolism, and the main organ of biotransformation and elimination of toxic substances and drugs, have many complex functions. Anesthetic drugs mostly through liver transformation and degradation.Liver cirrhosis, liver cancer patients due to abnormal liver dysfunction and liver metabolism, Most of the muscle relaxant prone to muscle relaxant accumulation and delayed recovery of patients with liver cirrhosis.
Mivacurium is a new type of non depolarizing muscle relaxants，has the characteristics of rapid onset, short duration of action. Mivacurium can produce similar clinical effect of depolarizing muscle relaxant succinylcholine, and rapidly be blood Che catabolism, Without liver metabolism. It can either as a single vein for medicinal endotracheal intubation, or as maintain continuous intravenous auxiliary anesthesia drug , is a muscle relaxant to shorten the clinical anesthesia recovery period ideal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients volunteered for the clinical research and signed a written informed consent
- •Experimental group patients is cirrhosis of the liver (liver function grade Child - Pugh, grade A) ready to abdominal surgery patients; The control group was no cirrhosis, ready to abdominal surgery patients
- •Aged 18 ~ 60
- •BMI<28kg/㎡
- •The American society of anesthesiologists (ASA) class I ~ II
排除标准
- •Systolic blood pressure ≥180 mm Hg or < 90 mm Hg, diastolic blood pressure ≥110 mm Hg or < 60 mm Hg
- •Serious heart, brain, liver, kidney, lung, endocrine diseases or serious infection
- •Patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.)
- •HR < 50 times/min
- •The patient had a history of mental illness or chronic psychiatric drugs, chronic pain medication history
- •History of alcoholism
- •Patients with neuromuscular system disease
- •Has a tendency to malignant hyperthermia
- •The patient used to test drug allergies or other contraindications
- •Over the past 30 days participated in other clinical drug research
研究组 & 干预措施
Mivacurium Chloride by liver dysfunction
Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance
干预措施: Mivacurium Chloride (Drug)
Mivacurium Chloride by normal liver function
Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance
干预措施: Mivacurium Chloride (Drug)
结局指标
主要结局
TOF ratio
时间窗: Time from administration to TOF (T4/T1) values recovered to 90%,an expected average of 25-30 minutes
次要结局
- Ramsay score(Time from the end of operation to extubation period,an expected average of 15 minutes)
- Steward score(Time from the end of operation to extubation period,an expected average of 15 minutes)
- Total duration of action(Time from the Mivacurium injection up to recovery from the neuromuscular blockade to 95% of the initial value,an expected average of 25-30 minutes)
- Recovery index(Time between a 25% and 75% recovery from a neuromuscular blockade,an expected average of 6-8 minutes)
- Mivacurium induced time(Time from intravenous injection of mivacurium to T1 reached the maximum inhibition time,an expected average of 3-5 minutes)
- Change of the mean arterial pressure (MAP) and heart rate (HR) during pulling out the endotracheal tube period(10 minutes before pulling the endotracheal tube, the moment of pulling the endotracheal tube immediately, pull out the endotracheal tube after 5 min)
- Clinical duration of action(Time from the Mivacurium injection up to recovery from the neuromuscular blockade to 25% of the initial value, an expected average of 12-20 minutes)
研究者
zhaoxiaoyong
Anesthesiologist
Tang-Du Hospital