Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis

Tang-Du Hospital

Status and phase: Unknown; Phase 2

Conditions: Liver Dysfunction

Treatments: Drug: Mivacurium Chloride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02473601

2015001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Mivacurium Chloride by liver dysfunction

Experimental group

Description:

Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance

Treatment:

Drug: Mivacurium Chloride

Mivacurium Chloride by normal liver function

Other group

Description:

Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance

Treatment:

Drug: Mivacurium Chloride