Effect of Succinylcholine on Patients Using Statins

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00986583
First received: September 23, 2009
Last updated: September 3, 2010
Last verified: September 2010
  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: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Effect of Succinylcholine on Patients Using Statins

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

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 ]
  • 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 ]

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)
Groups/Cohorts 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients scheduled for elective surgery with a planned endotracheal intubation while may or may not be taking statin medications.

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
Outcomes Research Consortium
Investigators
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Daniel Sessler, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00986583     History of Changes
Other Study ID Numbers: 09-683
Study First Received: September 23, 2009
Last Updated: September 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
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
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014