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Completed

NCT Number: NCT01511991

Sevoflurane's Effect on Mitral Valve Annular Velocity in Cardiac Surgery

The purpose of this study is to determine sevoflurane's dose-dependent effect on left ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular velocity at three different sevoflurane 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

Early Phase 1

Primary location

Konkuk University Medical Center

Seoul, 143-729, South Korea

About this study

Following data would be determined after 10 min-exposure to each dosage of sevoflurane with 1.0, 2.0 and 3.0 inspired vol% (T1, T2 and T3, respectively) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=14):

  • TDI of lateral mitral annulus at systole (S'), early filling (E') and atrial contraction (A')
  • transmitral flow Doppler at early filling (E), atrial contraction (A), deceleration time;
  • LV-ejection fraction (EF)
  • bispectral index (BIS)
  • phenylephrine-infusion rate
  • other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary wedge pressure (PCWP), mixed venous O2 saturation (SvO2), cardiac index (CI) and stroke volume index (SVI)

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 the mediastinum
  • upper gastrointestinal bleeding

Treatment and study plan

Sevoflurane dosage titration

Drug

comparisons of the effect of the 10 min-inhalation of each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3)

Other names: sevorane

Primary outcomes

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

    Time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%

    By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

  2. Peak mitral annular velocity during early filling (E')

    Time frame: after 10 min exposure to sevoflurane of 1.0 vol%, 2.0 vol% and 3.0 vol%

    By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, E' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

  3. peak mitral annular velocity during atrial contraction(A')

    Time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%

    By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, A' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

Secondary outcomes

  1. ejection fraction (EF)

    Time frame: after 10 min exposure to sevoflrane 1.0vol%, 2.0 vol% and 3.0 vol%

    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 sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

  2. bispectral index (BIS)

    Time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%

    BIS would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

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

    Time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%

    By using pulsed Doppler with the sample volume positioned at the lMV opening in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

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

    Time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%

    By using pulsed Doppler with the sample volume positioned at the tip of MV oeneing in the midesophageal 4-chamber view, "A" would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Sevoflurane's Effect on Tissue Doppler Profiles of Lateral Mitral Annulus During Cardiac Surgery

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jan 19, 2012
Registry last updated
Feb 24, 2015

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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