Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis

NCT02473601 | Unknown Phase 2

• 1 other identifier: 2015001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Dysfunction

Keywords

mivacurium chloramine; patients with liver cirrhosis; muscle relaxation effect

Outcome Measures

Primary Outcomes (1)

• TOF ratio

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

Secondary Outcomes (7)

• 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

Study Arms (2)

Mivacurium Chloride by liver dysfunction

EXPERIMENTAL

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

Drug: Mivacurium Chloride

Mivacurium Chloride by normal liver function

OTHER

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

Drug: Mivacurium Chloride

Interventions

Mivacurium Chloride 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.

Also known as: mivacurium, mivacron

Mivacurium Chloride by liver dysfunction; Mivacurium Chloride by normal liver function

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead
• Jiangsu Nhwa Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Tangdu hospital

Xi’an, Shanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Interventions

Mivacurium

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhao xiaoyong, master

CONTACT

13792601256; zhaolove120@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: May 24, 2015
• First Posted: June 16, 2015
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

CN (1)