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Completed

NCT Number: NCT00986583

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Succinylcholine

Drug

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

Primary outcomes

  1. Plasma Myoglobin Concentration

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

Secondary outcomes

  1. Muscle Pain

    Time frame: 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.

  2. Serum Potassium Concentration

    Time frame: At 5 and 20 min after succinylcholine

  3. Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively

    Time frame: 2 and 24 hours postoperatively

    Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively

  4. Duration of Succinylcholine Block

    Time frame: intraoperative: from succinylcholine administration

    Time required to reach maximum block by succinylcholine after succinylcholine administration.

  5. Fasciculation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 30, 2009
Registry last updated
Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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