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

Early Phase 1

Completed

• Conditions: Valvular Heart Disease
• Interventions: Drug: Sevoflurane dosage titration

• Registration Number: NCT01511991
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-13
• Study First Posted: 2012-01-19
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of