Interaction of Statins and Nondepolarizing Muscle Relaxants | NCT02222519

Studies
Interaction of Statins and Nondepolarizing Muscle Relaxants

NCT02222519

Sponsor

Huang-wei LV

Status

Unknown status

Last Update Posted

Oct 23, 2014Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Pain

Interventions

Rocuronium

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Sep 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Aug 14, 2014

First Submission Date that Met QC Criteria

Aug 20, 2014

First Posted Date

Aug 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2014

Last Update Posted Date

Oct 23, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Statin use group		patients taking statins for at least 3 months	Drug: Rocuronium
non statin use		no history of taking statin	Drug: Rocuronium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rocuronium	Drug	Rocuronium 0.6mg/kg iv single dose	Statin use group non statin use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
plasma myoglobin concentration		20 minutes after administration

Secondary Outcomes

Measure	Description	Time Frame
muscle pain		2 and 24 hours postoperatively
serum potassium concentration		2 and 24 hours postoperatively
plasma creatine phosphokinase concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Huangwei Lv, Professor	the Anesthesiology Department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University	Recruiting	Shenyang	Liaoning	110001	China

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D063806	Myalgia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009135	Muscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077123	Rocuronium

Ancestor Terms

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided