Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis

Liver Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02473601
• Other study ID #: 2015001
• Status: Recruiting
• Phase: Phase 2
• First received: May 24, 2015
• Last updated: August 20, 2015
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2015
• Source: Tang-Du Hospital
• Contact: zhao xiaoyong, master
• Phone: 13792601256
• Email: zhaolove120[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Dysfunction

Intervention

Drug:
• Mivacurium Chloride
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.

Locations

Country	Name	City	State
China	Tangdu hospital	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Tang-Du Hospital	Jiangsu Nhwa Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOF ratio		Time from administration to TOF (T4/T1) values recovered to 90%,an expected average of 25-30 minutes	No
Secondary	Steward score		Time from the end of operation to extubation period,an expected average of 15 minutes	Yes
Secondary	Ramsay score		Time from the end of operation to extubation period,an expected average of 15 minutes	Yes
Secondary	Mivacurium induced time		Time from intravenous injection of mivacurium to T1 reached the maximum inhibition time,an expected average of 3-5 minutes	No
Secondary	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	No
Secondary	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	No
Secondary	Recovery index		Time between a 25% and 75% recovery from a neuromuscular blockade,an expected average of 6-8 minutes	No
Secondary	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	Yes