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

Valvular Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511991
• Other study ID #: KUH1160037
• Status: Completed
• Phase: Early Phase 1
• First received: January 11, 2012
• Last updated: February 20, 2015
• Start date: May 2009
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Primary	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)	after 10 min exposure to sevoflurane of 1.0 vol%, 2.0 vol% and 3.0 vol%
Primary	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)	after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Secondary	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)	after 10 min exposure to sevoflrane 1.0vol%, 2.0 vol% and 3.0 vol%
Secondary	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)	after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Secondary	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)	after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Secondary	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)	after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%