The Effect of General Anesthesia on the Risk for Arrhythmia (10-02725)
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|ClinicalTrials.gov Identifier: NCT01174251|
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : October 8, 2013
Polymorphic ventricular tachycardia, known as Torsades de Pointes (TdP), is a specific form of ventricular arrhythmia with a characteristic twist of the QRS complex around the isoelectric baseline. TdP can degenerate into ventricular defibrillation followed by sudden cardiac death. A predictor for the development of TdP is the length of the QT interval measured on an EKG recording. The QT interval is known to be prolonged by many medications used in a perioperative setting as well as by other conditions such as hypothermia and electrolyte imbalance. General anesthesia exposes most of the investigators patients to a combination of several of those medications and conditions and therefore might increase the risk for the development of QT prolongation. Moreover, patient related risk factors are well known and aggravate the individual risk for potential life threatening TdP events when exposed to QT prolonging medications perioperatively.
Previous research suggests that more than 20% of the patients might develop QT prolongations perioperatively and are consequently on an increased risk for TdP; yet, no study has systematically investigated the magnitude of the problem and associated risk factors.
The proposed pilot study is designed as a prospective observational cohort study to investigate the QT interval before, during and after general anesthesia. It aims to determine the incidence of perioperative QT prolongations. A customary long term EKG recording device will be connected to a random sample of patients undergoing general anesthesia. Using these continuous EKG tracings, the lengths of the QT interval will be analyzed during the perioperative period.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||125 participants|
|Official Title:||The Effect of General Anesthesia on the Risk for Arrhythmia -A Pilot Study|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174251
|United States, California|
|UCSF Medical Center (Moffitt/Long, Mt. Zion)|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Kerstin Kolodzie, M.D., PhD||Dept. of Anesthesia & Perioperative Care; University of California, San Francisco (UCSF)|