Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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To Observe Mivacurium Chloramine Muscle Relaxation Effect in the Operation Anesthesia Patients With Liver Cirrhosis

Conditions
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Liver Dysfunction

Intervention / Treatment
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* Drug: Mivacurium Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mivacurium Chloride by liver dysfunction<br>Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance | Drug: Mivacurium Chloride<br>* Anesthesia induction: Intravenous injection of midazolam 0.05 mg/kg,Etomidate 0.3 mg/kg,Sufentanil 0.5 g/kg,TOF detection and adjustment of the first twitch height (T1)100%, Mivacurium Chloramine 0.07 mg/kg intraveous injecting in 5 minutes. Anesthesia maintenance: Two groups of sevoflurance 1% 8% inhalation anesthesia plus intravenous infusion of remifentanil 0.05～0.2 µg/kg/min,Mivacurium Chloramine 6mg/kg/h, Appropriate supplementary analgesia dose of sufentanil before skin incision and the abdomen was closed. The two groups were maintained until the Bis value was 40   60. PetCO2 was 30   35mmHg. Hemodynamic fluctuations did not exceed 20% of the baseline value.At least 20 minutes before the operation stopping Mivacurium infusion,Before the end of operation 5-10 minutes stopping infusion of remifentanil and sevoflurane.<br>* Other names: mivacron;|
| Other: Mivacurium Chloride by normal liver function<br>Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance | Drug: Mivacurium Chloride<br>* Anesthesia induction: Intravenous injection of midazolam 0.05 mg/kg,Etomidate 0.3 mg/kg,Sufentanil 0.5 g/kg,TOF detection and adjustment of the first twitch height (T1)100%, Mivacurium Chloramine 0.07 mg/kg intraveous injecting in 5 minutes. Anesthesia maintenance: Two groups of sevoflurance 1% 8% inhalation anesthesia plus intravenous infusion of remifentanil 0.05～0.2 µg/kg/min,Mivacurium Chloramine 6mg/kg/h, Appropriate supplementary analgesia dose of sufentanil before skin incision and the abdomen was closed. The two groups were maintained until the Bis value was 40   60. PetCO2 was 30   35mmHg. Hemodynamic fluctuations did not exceed 20% of the baseline value.At least 20 minutes before the operation stopping Mivacurium infusion,Before the end of operation 5-10 minutes stopping infusion of remifentanil and sevoflurane.<br>* Other names: mivacron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOF ratio |  | Time from administration to TOF (T4/T1) values recovered to 90%,an expected average of 25-30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steward score |  | Time from the end of operation to extubation period,an expected average of 15 minutes | 
| Ramsay score |  | Time from the end of operation to extubation period,an expected average of 15 minutes | 
| Mivacurium induced time |  | Time from intravenous injection of mivacurium to T1 reached the maximum inhibition time,an expected average of 3-5 minutes | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mivacurium chloramine, patients with liver cirrhosis, muscle relaxation effect