Effect of Succinylcholine on Patients Using Statins

Pain Clinical Trial

Official title:

Effect of Succinylcholine on Patients Using Statins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986583
• Other study ID #: 09-683
• Status: Completed
• Phase: N/A
• First received: September 23, 2009
• Last updated: September 3, 2010
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Outcomes Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Outcomes Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma myoglobin concentration		induction, 5 minutes after administration, 20 minutes and 24 hours post operatively	No
Secondary	muscle pain		2 and 24 hours postoperatively	No
Secondary	serum potassium concentration		2 and 24 hours postoperatively	No
Secondary	plasma CK concentration		2 and 24 hours postoperatively	No
Secondary	urine myoglobin and onset plus duration of succinylcholine block		2 and 24 hours postoperatively	No