Effect of Succinylcholine on Patients Using Statins

NCT00986583 | Completed Results DMC

• 1 other identifier: 09-683
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Succinylcholine; Statins; myalgias; statins with succinylcholine and pain

Outcome Measures

Primary Outcomes (1)

• Plasma Myoglobin Concentration

  induction, 5 minutes after administration, 20 minutes and 24 hours post operatively

Secondary Outcomes (5)

• Muscle 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

  2 and 24 hours postoperatively

• Duration of Succinylcholine Block

  intraoperative: from succinylcholine administration

• Fasciculation

  postoperative

Study Arms (2)

Statin use group

OTHER

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

Drug: Succinylcholine

non statin use

OTHER

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

Drug: Succinylcholine

Interventions

Succinylcholine DRUG

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

Statin use group; non statin use

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain; Myalgia

Interventions

Succinylcholine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Results Point of Contact

• Title: Alparslan Turan, M.D.
• Organization: Cleveland Clinic

turana@ccf.org

216-444-4000

Study Officials

• Alparsan Turan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 3, 2016
• Results First Posted: August 2, 2016

Record last verified: 2016-08

Locations

US (1)