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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Tae-Yop Kim, MD PhD, Konkuk University Medical Center

ClinicalTrials.gov Identifier:

NCT01511991

First received: January 11, 2012

Last updated: June 5, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 11, 2012

Last Updated Date

June 5, 2012

Start Date ^ICMJE

May 2009

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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% ] [ Designated as safety issue: No ]
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') [ Time Frame: after 10 min exposure to sevoflurane of 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
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') [ Time Frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01511991 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

ejection fraction (EF) [ Time Frame: after 10 min exposure to sevoflrane 1.0vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
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) [ Time Frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
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) [ Time Frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
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) [ Time Frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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)

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Valvular Heart Disease
Ischemic Heart Disease

Intervention ^ICMJE

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

Study Arm (s)

Experimental: sevoflurane

Intervention: Drug: Sevoflurane dosage titration

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01511991

Other Study ID Numbers ^ICMJE

KUH1160037

Has Data Monitoring Committee

Yes

Responsible Party

Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Study Sponsor ^ICMJE

Konkuk University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Tae-Yop Kim, MD PhD

Konkuk University Medical Center

Information Provided By

Konkuk University Medical Center

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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