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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01174251
First received: July 30, 2010
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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
Arrhythmia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of General Anesthesia on the Risk for Arrhythmia -A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Enrollment: 125
Study Start Date: December 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174251

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01174251     History of Changes
Other Study ID Numbers: H61125-34760-01
Study First Received: July 30, 2010
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014