Effect of Succinylcholine on Patients Using Statins
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Plasma Myoglobin Concentration
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Statin use group
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Intervention: Succinylcholine (Drug)
non statin use
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Intervention: Succinylcholine (Drug)
Outcomes
Primary Outcomes
Plasma Myoglobin Concentration
Time Frame: induction, 5 minutes after administration, 20 minutes and 24 hours post operatively
Secondary Outcomes
- Serum Potassium Concentration(At 5 and 20 min after succinylcholine)
- Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively(2 and 24 hours postoperatively)
- Muscle Pain(2 and 24 hours postoperatively)
- Duration of Succinylcholine Block(intraoperative: from succinylcholine administration)
- Fasciculation(postoperative)
Investigators
Alparslan Turan
Principal Investigator
The Cleveland Clinic