Clinical trial NCT02473601: Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis
Official title: To Observe Mivacurium Chloramine Muscle Relaxation Effect in the Operation Anesthesia Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Dysfunction
Keywords: mivacurium chloramine
patients with liver cirrhosis
muscle relaxation effect
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Nhwa Pharmaceutical Co., Ltd.
First posted: 2015-06-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: TOF ratio
timeFrame: Time from administration to TOF (T4/T1) values recovered to 90%,an expected average of 25-30 minutes
Secondary outcomes:
measure: Steward score
timeFrame: Time from the end of operation to extubation period,an expected average of 15 minutes
measure: Ramsay score
timeFrame: Time from the end of operation to extubation period,an expected average of 15 minutes
measure: Mivacurium induced time
timeFrame: Time from intravenous injection of mivacurium to T1 reached the maximum inhibition time,an expected average of 3-5 minutes
measure: Clinical duration of action
timeFrame: 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
measure: Total duration of action
timeFrame: 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
measure: Recovery index
timeFrame: Time between a 25% and 75% recovery from a neuromuscular blockade,an expected average of 6-8 minutes
measure: Change of the mean arterial pressure (MAP) and heart rate (HR) during pulling out the endotracheal tube period
timeFrame: 10 minutes before pulling the endotracheal tube, the moment of pulling the endotracheal tube immediately, pull out the endotracheal tube after 5 min
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu hospital
state: Shanxi
Study officials:
affiliation: Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital
name: zhao xiaoyong, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital
name: sun meiyan, master
role: PRINCIPAL_INVESTIGATOR
References: