PainNCT02222519
Interaction of Statins and Nondepolarizing Muscle Relaxants
An observational study of Pain, run by Huang-wei LV at 1 site in China.
Trial summary
provide evidence for prevention or reduction muscle pain. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Rocuronium
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Sep 2015
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Orthopedic
- Spinal surgery
- Surgery involving extensive muscle manipulation
- History of liver and kidney failure
- Neuromuscular disease
- Susceptibility to or family history of malignant hyperthermia
Show all 9Show fewer
- Extensive denervation of skeletal muscle
- Chronic pain syndromes
- Taking medications that might interact with the effect of rocuronium or serum myoglobin difficult intubation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China Medical University
Shenyang, Liaoning, 110001
Huang-wei Lv, Professor, 86-024-83283100, hwl1998@yahoo.com
Huang-wei LV, Professor
About this study
provide evidence for prevention or reduction muscle pain.
Read the 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.
- Conditions
- Pain
- Being tested
- Rocuronium
- Keywords
- statins, nondepolarizing muscle relaxants, rocuronium, myalgia
- Medical subject headings
- Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Rocuronium Bromide Injection, Esmeron, http://www.msdchina.com.cn/
Rocuronium 0.6mg/kg iv single dose
| Study group | Role | What they receive |
|---|---|---|
| Statin use group | patients taking statins for at least 3 months Receives: Drug: Rocuronium | |
| non statin use | no history of taking statin Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma myoglobin concentration
Measured: 20 minutes after administration
Secondary outcomes (4)
muscle pain
Measured: 2 and 24 hours postoperatively
serum potassium concentration
Measured: 2 and 24 hours postoperatively
plasma creatine phosphokinase concentration
Measured: 2 and 24 hours postoperatively
urine myoglobin and onset plus duration of succinylcholine block
Measured: 2 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (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 PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huang-wei LV
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huang-wei LV, First Hospital of China Medical University
- Investigators
- Huangwei Lv, Professor, Study director, the Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222519
- Sponsor's protocol ID
- 2014071801
- Status last verified
- Oct 2014
- First submitted
- 14 Aug 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Statins and Nondepolarizing Muscle Relaxants
- ClinicalTrials.gov ID
- NCT02222519
- Acronym / sponsor ID
- 2014071801
- Conditions
- Pain
- Keywords
- statins, nondepolarizing muscle relaxants, rocuronium, myalgia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huang-wei LVUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 21 Aug 2014 (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.
provide evidence for prevention or reduction muscle pain.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin use group | – | Drug: Rocuroniumpatients taking statins for at least 3 months |
| non statin use | – | Drug: Rocuroniumno history of taking statin |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- Orthopedic
- Spinal surgery
- Surgery involving extensive muscle manipulation
- History of liver and kidney failure
- Neuromuscular disease
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 |
|---|---|---|
| RocuroniumAlso: Rocuronium Bromide Injection, Esmeron, http://www.msdchina.com.cn/Rocuronium 0.6mg/kg iv single dose | Drug | Statin use group, non statin use |
Primary outcome
plasma myoglobin concentration
Time frame: 20 minutes after administration
4 secondary outcomes
muscle pain
Time frame: 2 and 24 hours postoperatively
serum potassium concentration
Time frame: 2 and 24 hours postoperatively
plasma creatine phosphokinase concentration
Time frame: 2 and 24 hours postoperatively
urine myoglobin and onset plus duration of succinylcholine block
Time frame: 2 and 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
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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.
Huangwei Lv, Professor study director
the Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Huang-wei LV 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 2 inclusion and 9 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 23 Oct 2014. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma myoglobin concentration (time frame: 20 minutes after administration). 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 23 Oct 2014.