Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis

NCT ID: NCT02473601

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-09-30

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.

Conditions

Liver Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mivacurium Chloride by liver dysfunction

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

Group Type: EXPERIMENTAL

Mivacurium Chloride

Intervention Type: DRUG

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.

Mivacurium Chloride by normal liver function

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

Group Type: OTHER

Mivacurium Chloride

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

mivacurium; mivacron

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Nhwa Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

zhaoxiaoyong

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhao xiaoyong, master

Role: PRINCIPAL_INVESTIGATOR

Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital

sun meiyan, master

Role: PRINCIPAL_INVESTIGATOR

Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital

Locations

Tangdu hospital

Xi’an, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

zhao xiaoyong, master

Role: CONTACT

zhaolove120@163.com

13792601256

Facility Contacts

zhao xiaoyong, master

Role: primary

zhaolove120@163.com

13792601256

Other Identifiers

2015001

Identifier Type: -

Identifier Source: org_study_id