Effect of Succinylcholine on Patients Using Statins

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 Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Succinylcholine

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Alparsan Turan, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: September 23, 2009
• First Submitted That Met QC Criteria: September 29, 2009
• First Posted (Estimate): September 30, 2009

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Statins; Succinylcholine; myalgias; statins with succinylcholine and pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Succinylcholine
• Other Study ID Numbers: 09-683