Effect of Succinylcholine on Patients Using Statins

NCT ID: NCT00986583

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-07-31

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.

Conditions

Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Statin use group

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

Group Type: OTHER

Succinylcholine

Intervention Type: DRUG

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.

Group Type: OTHER

Succinylcholine

Intervention Type: DRUG

Succinylcholine will be administered pre-induction over a period of 5 seconds

Interventions

Succinylcholine

Succinylcholine will be administered pre-induction over a period of 5 seconds

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Alparslan Turan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alparsan Turan, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

09-683

Identifier Type: -

Identifier Source: org_study_id