Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis

Sponsor

Tang-Du Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02473601

Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd. (Industry)

Enrollment

Location

Arms

Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Liver Dysfunction	Drug: Mivacurium Chloride	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2015

Anticipated Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mivacurium Chloride by liver dysfunction Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance	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. Other Names: mivacurium mivacron
Other: Mivacurium Chloride by normal liver function Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance	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. Other Names: mivacurium mivacron

Arm

Intervention/Treatment

Experimental: Mivacurium Chloride by liver dysfunction

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

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.

Other Names:

mivacurium

mivacron

Other: Mivacurium Chloride by normal liver function

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

Drug: Mivacurium Chloride

Other Names:

mivacurium

mivacron

Outcome Measures

Primary Outcome Measures

TOF ratio [Time from administration to TOF (T4/T1) values recovered to 90%,an expected average of 25-30 minutes]

Secondary Outcome Measures

Steward score [Time from the end of operation to extubation period,an expected average of 15 minutes]
Ramsay score [Time from the end of operation to extubation period,an expected average of 15 minutes]
Mivacurium induced time [Time from intravenous injection of mivacurium to T1 reached the maximum inhibition time,an expected average of 3-5 minutes]
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]
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]
Recovery index [Time between a 25% and 75% recovery from a neuromuscular blockade,an expected average of 6-8 minutes]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tangdu hospital	Xi'an	Shanxi	China	710038

Sponsors and Collaborators

Tang-Du Hospital
Jiangsu Nhwa Pharmaceutical Co., Ltd.

Investigators

Principal Investigator: zhao xiaoyong, master, Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital
Principal Investigator: sun meiyan, master, Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital