- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02222519
Interaction of Statins and Nondepolarizing Muscle Relaxants
October 22, 2014 updated by: Huang-wei LV
provide evidence for prevention or reduction muscle pain.
Study Overview
Detailed Description
The purpose of this study is to determine interaction of statins and nondepolarizing muscle relaxant,In order to provide evidence for prevention or reduction muscle pain.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110001
- Recruiting
- China Medical University
-
Contact:
- Huang-wei Lv, Professor
- Phone Number: 86-024-83283100
- Email: hwl1998@yahoo.com
-
Principal Investigator:
- Huang-wei LV, Professor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months
Description
Inclusion Criteria:
- Patients with American Society of Anesthesiologists physical status I-III
- Patients taking statins for at least 3 months and those who had never used statins were considered to be eligible
Exclusion Criteria:
- Orthopedic
- Spinal surgery
- Surgery involving extensive muscle manipulation
- History of liver and kidney failure
- Neuromuscular disease
- Susceptibility to or family history of malignant hyperthermia
- Extensive denervation of skeletal muscle
- Chronic pain syndromes
- Taking medications that might interact with the effect of rocuronium or serum myoglobin difficult intubation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Statin use group
patients taking statins for at least 3 months
|
Rocuronium 0.6mg/kg iv single dose
Other Names:
|
non statin use
no history of taking statin
|
Rocuronium 0.6mg/kg iv single dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma myoglobin concentration
Time Frame: 20 minutes after administration
|
20 minutes after administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
muscle pain
Time Frame: 2 and 24 hours postoperatively
|
2 and 24 hours postoperatively
|
serum potassium concentration
Time Frame: 2 and 24 hours postoperatively
|
2 and 24 hours postoperatively
|
plasma creatine phosphokinase concentration
Time Frame: 2 and 24 hours postoperatively
|
2 and 24 hours postoperatively
|
urine myoglobin and onset plus duration of succinylcholine block
Time Frame: 2 and 24 hours postoperatively
|
2 and 24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Huangwei Lv, Professor, the Anesthesiology Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
August 14, 2014
First Submitted That Met QC Criteria
August 20, 2014
First Posted (Estimate)
August 21, 2014
Study Record Updates
Last Update Posted (Estimate)
October 23, 2014
Last Update Submitted That Met QC Criteria
October 22, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014071801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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