Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis
Information source: Tang-Du Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Dysfunction
Intervention: Mivacurium Chloride (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Tang-Du Hospital Official(s) and/or principal investigator(s): zhao xiaoyong, master, Principal Investigator, Affiliation: Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital sun meiyan, master, Principal Investigator, Affiliation: Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital
Overall contact: zhao xiaoyong, master, Phone: 13792601256, Email: zhaolove120@163.com
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
Clinical Details
Official title: To Observe Mivacurium Chloramine Muscle Relaxation Effect in the Operation Anesthesia Patients With Liver Cirrhosis
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: TOF ratio
Secondary outcome: Steward scoreRamsay score Mivacurium induced time Clinical duration of action Total duration of action Recovery index Change of the mean arterial pressure (MAP) and heart rate (HR) during pulling out the endotracheal tube period
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
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
zhao xiaoyong, master, Phone: 13792601256, Email: zhaolove120@163.com
Tangdu hospital, Xi'an, Shanxi 710038, China; Recruiting zhao xiaoyong, master, Phone: 13792601256, Email: zhaolove120@163.com sun meiyan, master, Sub-Investigator zhang lianhua, master, Sub-Investigator gao changjun, doctor, Sub-Investigator sun xude, master, Sub-Investigator
Additional Information
Starting date: October 2014
Last updated: August 20, 2015
|