The Effect of General Anesthesia on the Risk for Arrhythmia

NCT ID: NCT01174251

Last Updated: 2013-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arrhythmia

Keywords

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general anesthesia electrocardiography long QT syndrome, acquired

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kerstin Kolodzie, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Anesthesia & Perioperative Care; University of California, San Francisco (UCSF)

Locations

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UCSF Medical Center (Moffitt/Long, Mt. Zion)

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H61125-34760-01

Identifier Type: -

Identifier Source: org_study_id