Effect of Succinylcholine on Patients Using Statins

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Succinylcholine on Patients Using Statins

Conditions
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Pain

Intervention / Treatment
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* Drug: Succinylcholine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Statin use group<br>Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. | Drug: Succinylcholine<br>* Succinylcholine will be administered pre-induction over a period of 5 seconds<br>|
| Other: non statin use<br>Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. | Drug: Succinylcholine<br>* Succinylcholine will be administered pre-induction over a period of 5 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Myoglobin Concentration |  | induction, 5 minutes after administration, 20 minutes and 24 hours post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Pain | 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. | 2 and 24 hours postoperatively | 
| Serum Potassium Concentration |  | At 5 and 20 min after succinylcholine | 
| Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively | Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively | 2 and 24 hours postoperatively | 
| Duration of Succinylcholine Block | Time required to reach maximum block by succinylcholine after succinylcholine administration. | intraoperative: from succinylcholine administration | 
| Fasciculation | 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. | postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Succinylcholine, Statins, myalgias, statins with succinylcholine and pain