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Completed

NCT Number: NCT01819012

Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery

The purpose of this study is to determine Isoflurane's dose-dependent effect on left ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery patients.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konkuk University Medical Center

Seoul, 143-729, South Korea

About this study

Isoflurane is widely used in cardiac surgery patients due to its beneficial effects, but many studies have shown that isoflurane reduces myocardial contractility in a dose-dependent manner, and compromises left ventricular (LV) function.

Tissue Doppler imaging (TDI) of mitral annular velocity during the cardiac cycle has been introduced as a reliable method for analysis of systolic and diastolic LV long-axis function. Efficacy of systolic and diastolic TDI profiles, including systole (S'), early early relaxation (E')and atrial contraction (A') have been suggested to be useful in predicting the impact of isoflurane on LV systolic and diastolic function.

The investigators hypothesized that isoflurane, even at a clinical dosage, would affects intraoperative LV systolic function in a dose-dependent manner and thus produce significant changes int the TDI profiles of systolic mitral annular velocity (S').

So the investigators planned to study the changes in S' of lateral mitral annulus at the clinical isoflurane dosage during remifentanil based anesthesia for cardiac surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing cardiac surgery

Exclusion criteria

  • low ejection fraction < 50% in preoperative transthoracic echocardiography
  • atrial fibrillation
  • pacemaker
  • pericardial and infiltrative myocardial disease
  • mitral annular calcification, surgical rings, prosthetic mitral valves
  • lateral left ventricular regional wall motion abnormality
  • esophageal spasm, stricture, laceration, perforation, and diverticulum diaphragmatic hernia
  • history of extensive radiation to mediastinum
  • upper gastrointestinal bleeding

Treatment and study plan

Isoflurane 1.0 MAC

Drug

10 min-inhalation of each concentration of isoflurane, 1.0 MAC

Isoflurane 1.5 MAC

Drug

10 min-inhalation of each concentration of isoflurane, 1.5 MAC

Isoflurane 2.0 MAC

Drug

10 min-inhalation of each concentration of isoflurane, 2.0 MAC

Primary outcomes

  1. Peak mitral annular velocity during systole(S')

    Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

    By using pulsed Doppler with the sample volume positioned at the lateral mitral valve (MV)ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC (T1, T2 and T3, respectively)

Secondary outcomes

  1. ejection fraction(EF)

    Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

    By using modified Simpson technique in the midesophageal 4-chamber view, EF would be determined just after the 10 min-exposure to each concentration of isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

  2. bispectral index(BIS)

    Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

    BIS would be determined just after the 10 min-exposure to each concentration of isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

  3. peak velocity of mitral inflow during early relaxation(E)

    Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

    By using pulsed Doppler with the sample volume positioned at the IMV opening in the midesophageal 4-chamber view, E' would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC(T1, T2 and T3, respectively)

  4. peak velocity of mitral inflow during atrial contraction(A)

    Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

    By using pulsed Doppler with the sample volume positioned at the tip of MV opening in the midesophageal 4-chamber view, "A" would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC(T1, T2 and T3, respectively)

  5. Peak mitral annular velocity during early diastole(E')

    Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

    By using pulsed Doppler with the sample volume positioned at the lateral MV ring

  6. Peak mitral annular velocity during atrial contraction(A')

    Time frame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

    By using pulsed Doppler with the sample volume positioned at the lateral MV ring

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 27, 2013
Registry last updated
Nov 2, 2016

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

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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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