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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

September 23, 2009
August 24, 2016
September 2009
July 2010   (final data collection date for primary outcome measure)
Plasma Myoglobin Concentration [ Time Frame: induction, 5 minutes after administration, 20 minutes and 24 hours post operatively ] [ Designated as safety issue: No ]
plasma myglobulin concentration [ Time Frame: induction, 5 minutes after administration, 20 minutes and 24 hours post operatively ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00986583 on ClinicalTrials.gov Archive Site
  • Muscle Pain [ Time Frame: 2 and 24 hours postoperatively ] [ Designated as safety issue: No ]

    verbal rating scale score and the pain score both at 2 and 24 hours postoperatively.

    The verbal rating scale score ranges from 0 (no pain) to 100 (worst pain imaginable).

    The pain score ranges from 0 to 3: 0 none; 1 muscle stiffness or pain in the nape of the neck, shoulders, and chest; 2 muscle stiffness and pain requiring analgesia; and 3 incapacitating generalized muscle stiffness or pain.

  • Serum Potassium Concentration [ Time Frame: At 5 and 20 min after succinylcholine ] [ Designated as safety issue: No ]
  • Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively [ Time Frame: 2 and 24 hours postoperatively ] [ Designated as safety issue: No ]
    Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively
  • Duration of Succinylcholine Block [ Time Frame: intraoperative: from succinylcholine administration ] [ Designated as safety issue: No ]
    Time required to reach maximum block by succinylcholine after succinylcholine administration.
  • Fasciculation [ Time Frame: postoperative ] [ Designated as safety issue: No ]
    The fasciculation ranges from 0 to 3: 0 none; 1 small movements around eyes and fingers; 2 moderate movements in face, neck, fingers, and trunk; and 3 vigorous movements in trunk and extremities.
  • Muscle Pain [ Time Frame: 2 and 24 hours postoperatively ] [ Designated as safety issue: No ]
  • Serum Potassium Concentration [ Time Frame: 2 and 24 hours postoperatively ] [ Designated as safety issue: No ]
  • plasma CK concentration [ Time Frame: 2 and 24 hours postoperatively ] [ Designated as safety issue: No ]
  • urine myoglobin and onset plus duration of succinylcholine block [ Time Frame: 2 and 24 hours postoperatively ] [ Designated as safety issue: No ]
Not Provided
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Effect of Succinylcholine on Patients Using Statins
Effect of Succinylcholine on Patients Using Statins
Based on available mechanistic and clinical information, the investigators propose a nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The investigators' purpose is to evaluate the effect of succinylcholine on patients taking statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal, vascular or muscle) with planned endotracheal intubation will be approached regarding participation in the trial. Design of the study is complex because there is no way to randomize patients to statins or no statins and also no way to take them off the statins prior surgery. So statin use will not be randomized; confounding factors will be accounted for by stratification (every 10 years of age from 40-80 and gender) and statistical adjustment. The investigators propose to test the hypothesis that succinylcholine administration increases plasma myoglobin concentration more in patients who are on statins compared to patients who do not.
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Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
Drug: Succinylcholine
Succinylcholine will be administered pre-induction over a period of 5 seconds
  • Statin use group
    Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
    Intervention: Drug: Succinylcholine
  • non statin use
    Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
    Intervention: Drug: Succinylcholine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled for elective surgery not involving orthopedic procedure, muscle and spinal surgery
  • ASA Physical Status 1-3

Exclusion Criteria:

  • History of liver failure
  • History of renal failure
  • History of neuromuscular disease
  • Increased intraocular pressure
  • Recent major burn
  • Multiple trauma
  • Susceptibility to or family history of malignant hyperthermia
Both
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00986583
09-683
Yes
Not Provided
Not Provided
Alparslan Turan, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Alparsan Turan, MD The Cleveland Clinic
The Cleveland Clinic
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP