Effect of Succinylcholine on Patients Using Statins

NeuroTherapia, Inc.

Status: Completed

Conditions: Pain

Treatments: Drug: Succinylcholine

Study type: Interventional

Funder types: Other

Identifiers

NCT00986583

09-683

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Statin use group

Other group

Description:

Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.

Treatment:

Drug: Succinylcholine

non statin use

Other group

Description:

Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.

Treatment:

Drug: Succinylcholine