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

Primary Purpose

Valvular Heart Disease

Status
Completed
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sevoflurane dosage titration
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Valvular Heart Disease focused on measuring cardiac surgery, sevoflurane, tissue Doppler

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Konkuk University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sevoflurane

Arm Description

10 min exposure to sevoflurane 1.0, 2.0 and 3.0 inspiratory vol% at sevoflurane dosage titration

Outcomes

Primary Outcome Measures

Peak mitral annular velocity during systole (S')
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)
Peak mitral annular velocity during early filling (E')
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)
peak mitral annular velocity during atrial contraction(A')
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

ejection fraction (EF)
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)
bispectral index (BIS)
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)
peak velocity of mitral inflow during early relaxation (E)
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)
peak velocity of mitral inflow during atrial contraction (A)
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)

Full Information

First Posted
January 11, 2012
Last Updated
February 20, 2015
Sponsor
Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01511991
Brief Title
Sevoflurane's Effect on Mitral Valve Annular Velocity in Cardiac Surgery
Official Title
Sevoflurane's Effect on Tissue Doppler Profiles of Lateral Mitral Annulus During Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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): 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
Keywords
cardiac surgery, sevoflurane, tissue Doppler

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sevoflurane
Arm Type
Experimental
Arm Description
10 min exposure to sevoflurane 1.0, 2.0 and 3.0 inspiratory vol% at sevoflurane dosage titration
Intervention Type
Drug
Intervention Name(s)
Sevoflurane dosage titration
Other Intervention Name(s)
sevorane
Intervention Description
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)
Primary Outcome Measure Information:
Title
Peak mitral annular velocity during systole (S')
Description
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)
Time Frame
after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Title
Peak mitral annular velocity during early filling (E')
Description
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)
Time Frame
after 10 min exposure to sevoflurane of 1.0 vol%, 2.0 vol% and 3.0 vol%
Title
peak mitral annular velocity during atrial contraction(A')
Description
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)
Time Frame
after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Secondary Outcome Measure Information:
Title
ejection fraction (EF)
Description
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)
Time Frame
after 10 min exposure to sevoflrane 1.0vol%, 2.0 vol% and 3.0 vol%
Title
bispectral index (BIS)
Description
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)
Time Frame
after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Title
peak velocity of mitral inflow during early relaxation (E)
Description
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)
Time Frame
after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Title
peak velocity of mitral inflow during atrial contraction (A)
Description
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)
Time Frame
after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Yop Kim, MD PhD
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
14566295
Citation
Bruch C, Gradaus R, Gunia S, Breithardt G, Wichter T. Doppler tissue analysis of mitral annular velocities: evidence for systolic abnormalities in patients with diastolic heart failure. J Am Soc Echocardiogr. 2003 Oct;16(10):1031-6. doi: 10.1016/S0894-7317(03)00634-5.
Results Reference
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PubMed Identifier
11734780
Citation
Waggoner AD, Bierig SM. Tissue Doppler imaging: a useful echocardiographic method for the cardiac sonographer to assess systolic and diastolic ventricular function. J Am Soc Echocardiogr. 2001 Dec;14(12):1143-52. doi: 10.1067/mje.2001.115391.
Results Reference
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Sevoflurane's Effect on Mitral Valve Annular Velocity in Cardiac Surgery

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