Effect of Succinylcholine on Patients Using Statins

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Succinylcholine

• Registration Number: NCT00986583
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2015-12-24
• Results First Submitted QC: 2016-06-20
• Status Verified: 2016-08
• Results First Posted: 2016-08-02
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Scheduled for elective surgery not involving orthopedic procedure, muscle and spinal surgery
• ASA Physical Status 1-3

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin use group	Succinylcholine	Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
non statin use	Succinylcholine	Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.

Primary Outcome Measures

Name	Time	Method
Plasma Myoglobin Concentration	induction, 5 minutes after administration, 20 minutes and 24 hours post operatively

Secondary Outcome Measures

Name	Time	Method
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	Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively
Muscle Pain	2 and 24 hours postoperatively	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.
Duration of Succinylcholine Block	intraoperative: from succinylcholine administration	Time required to reach maximum block by succinylcholine after succinylcholine administration.
Fasciculation	postoperative	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.

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States