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Effect of Succinylcholine on Patients Using Statins

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alparslan Turan, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00986583
First received: September 23, 2009
Last updated: August 24, 2016
Last verified: August 2016
Results First Received: December 24, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain
Intervention: Drug: Succinylcholine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least 3 months and those who had never used statins were considered to be eligible for participation. We included patients scheduled for elective surgery (October 2009 between June 2010) in this comparative, prospective, nonrandomized study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Statin Use Group

Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.

Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds

Non Statin Use

Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.

Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds


Participant Flow:   Overall Study
    Statin Use Group   Non Statin Use
STARTED   38   32 
COMPLETED   38   32 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Statin Use Group

Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.

Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds.

Non Statin Use

Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.

Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds

Total Total of all reporting groups

Baseline Measures
   Statin Use Group   Non Statin Use   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   32   70 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (9)   57  (10)   59  (10) 
Gender 
[Units: Participants]
     
Female   16   15   31 
Male   22   17   39 
Region of Enrollment 
[Units: Participants]
     
United States   38   32   70 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Plasma Myoglobin Concentration   [ Time Frame: induction, 5 minutes after administration, 20 minutes and 24 hours post operatively ]

2.  Secondary:   Muscle Pain   [ Time Frame: 2 and 24 hours postoperatively ]

3.  Secondary:   Serum Potassium Concentration   [ Time Frame: At 5 and 20 min after succinylcholine ]

4.  Secondary:   Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively   [ Time Frame: 2 and 24 hours postoperatively ]

5.  Secondary:   Duration of Succinylcholine Block   [ Time Frame: intraoperative: from succinylcholine administration ]

6.  Secondary:   Fasciculation   [ Time Frame: postoperative ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alparslan Turan, M.D.
Organization: Cleveland Clinic
phone: 216-444-4000 ext 9857
e-mail: turana@ccf.org



Responsible Party: Alparslan Turan, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00986583     History of Changes
Other Study ID Numbers: 09-683
Study First Received: September 23, 2009
Results First Received: December 24, 2015
Last Updated: August 24, 2016