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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 score

Ramsay 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

Page last updated: August 23, 2015

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