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Trial record 61 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

The Effect of General Anesthesia on the Risk for Arrhythmia (10-02725)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01174251
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : October 8, 2013
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A simple random sample will be chosen among all patients scheduled for general anesthesia in the UCSF affiliations Mt. Zion Hospital and Moffit/Long Hospital meeting all inclusion- and exclusion criteria.

Inclusion Criteria:

  • Male and female ASA I - III patients
  • Age 18 years and older
  • Scheduled for general anesthesia with a duration of at least 1 hour

Exclusion Criteria:

  • Cardiac or thoracic surgery
  • Planed postoperative ICU admission
  • Non-English speaking
  • Not in sinus rhythm
  • Left and right bundle branch block
  • Implanted pacemaker
  • Mentally impaired

Information from the National Library of Medicine

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 identifier (NCT number): NCT01174251

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United States, California
UCSF Medical Center (Moffitt/Long, Mt. Zion)
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Kerstin Kolodzie, M.D., PhD Dept. of Anesthesia & Perioperative Care; University of California, San Francisco (UCSF)

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Responsible Party: University of California, San Francisco Identifier: NCT01174251     History of Changes
Other Study ID Numbers: H61125-34760-01
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013

Keywords provided by University of California, San Francisco:
general anesthesia
long QT syndrome, acquired

Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs