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

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ClinicalTrials.gov Identifier: NCT01511991
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Valvular Heart Disease Drug: Sevoflurane dosage titration Early Phase 1

Detailed Description:

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):

  1. TDI of lateral mitral annulus at systole (S'), early filling (E') and atrial contraction (A')
  2. transmitral flow Doppler at early filling (E), atrial contraction (A), deceleration time;
  3. LV-ejection fraction (EF)
  4. bispectral index (BIS)
  5. phenylephrine-infusion rate
  6. 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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Sevoflurane's Effect on Tissue Doppler Profiles of Lateral Mitral Annulus During Cardiac Surgery
Study Start Date : May 2009
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Sevoflurane
U.S. FDA Resources

Arm Intervention/treatment
Experimental: sevoflurane
10 min exposure to sevoflurane 1.0, 2.0 and 3.0 inspiratory vol% at sevoflurane dosage titration
Drug: Sevoflurane dosage titration
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 Name: sevorane



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01511991


Locations
Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
Principal Investigator: Tae-Yop Kim, MD PhD Konkuk University Medical Center

Publications:
Responsible Party: Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01511991     History of Changes
Other Study ID Numbers: KUH1160037
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015

Keywords provided by Tae-Yop Kim, MD PhD, Konkuk University Medical Center:
cardiac surgery
sevoflurane
tissue Doppler

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs