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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
  Purpose
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.

Condition Intervention
Pain
Drug: Succinylcholine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Succinylcholine on Patients Using Statins

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Plasma Myoglobin Concentration [ Time Frame: induction, 5 minutes after administration, 20 minutes and 24 hours post operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 70
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Statin use group
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Drug: 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.
Drug: Succinylcholine
Succinylcholine will be administered pre-induction over a period of 5 seconds

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986583

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Alparsan Turan, MD The Cleveland Clinic
  More Information

Responsible Party: Alparslan Turan, Principal Investigator, 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
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Succinylcholine
Statins
myalgias
statins with succinylcholine and pain

Additional relevant MeSH terms:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Succinylcholine
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016