Liver DysfunctionPhase 2NCT02473601
Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis
A Phase 2 study testing Mivacurium Chloride in people with Liver Dysfunction, run by Tang-Du Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Dysfunction
- What is being tested?
- Mivacurium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu hospital
Xi’an, Shanxi, 710038
zhao xiaoyong, master, 13792601256, zhaolove120@163.com
sun meiyan, master
About this study
Official title: To Observe Mivacurium Chloramine Muscle Relaxation Effect in the Operation Anesthesia Patients With Liver Cirrhosis
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
Read the 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
- Being tested
- Mivacurium Chloride
- Keywords
- mivacurium chloramine, patients with liver cirrhosis, muscle relaxation effect
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mivacurium ChlorideDrug
Also called mivacurium, mivacron
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.
| Study group | Role | What they receive |
|---|---|---|
| Mivacurium Chloride by liver dysfunction | Experimental | Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance Receives: 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 Receives: Drug: Mivacurium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
TOF ratio
Measured: Time from administration to TOF (T4/T1) values recovered to 90%,an expected average of 25-30 minutes
Secondary outcomes (7)
Steward score
Measured: Time from the end of operation to extubation period,an expected average of 15 minutes
Ramsay score
Measured: Time from the end of operation to extubation period,an expected average of 15 minutes
Mivacurium induced time
Measured: Time from intravenous injection of mivacurium to T1 reached the maximum inhibition time,an expected average of 3-5 minutes
Clinical duration of action
Measured: 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
Measured: 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
Measured: 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
Measured: 10 minutes before pulling the endotracheal tube, the moment of pulling the endotracheal tube immediately, pull out the endotracheal tube after 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startOct 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DysfunctionStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, zhaoxiaoyong, Tang-Du Hospital
- Investigators
- zhao xiaoyong, master, Principal investigator, Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospitalsun meiyan, master, Principal investigator, Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473601
- Sponsor's protocol ID
- 2015001
- Status last verified
- Aug 2015
- First submitted
- 24 May 2015
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Observe Mivacurium Chloramine Muscle Relaxation Effect in the Operation Anesthesia Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02473601
- Acronym / sponsor ID
- 2015001
- Conditions
- Liver Dysfunction
- Keywords
- mivacurium chloramine, patients with liver cirrhosis, muscle relaxation effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mivacurium Chloride by liver dysfunction | Experimental | Drug: Mivacurium ChlorideMivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance |
| Mivacurium Chloride by normal liver function | Other | Drug: Mivacurium ChlorideMivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mivacurium ChlorideAlso: mivacurium, mivacronAnesthesia 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. | Drug | Mivacurium Chloride by liver dysfunction, Mivacurium Chloride by normal liver function |
Primary outcome
TOF ratio
Time frame: Time from administration to TOF (T4/T1) values recovered to 90%,an expected average of 25-30 minutes
7 secondary outcomes
Steward score
Time frame: Time from the end of operation to extubation period,an expected average of 15 minutes
Ramsay score
Time frame: Time from the end of operation to extubation period,an expected average of 15 minutes
Mivacurium induced time
Time frame: 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 frame: 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 frame: 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 frame: 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
Time frame: 10 minutes before pulling the endotracheal tube, the moment of pulling the endotracheal tube immediately, pull out the endotracheal tube after 5 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
Related trials for Liver Dysfunction
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhao xiaoyong, master principal investigator
Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital
sun meiyan, master principal investigator
Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mivacurium Chloride in people with Liver Dysfunction, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhao xiaoyong, master (13792601256, zhaolove120@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TOF ratio (time frame: Time from administration to TOF (T4/T1) values recovered to 90%,an expected average of 25-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.