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

NCT01511991 | Completed Early Phase 1 DMC

• 1 other identifier: KUH1160037
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvular Heart Disease

Keywords

cardiac surgery; sevoflurane; tissue Doppler

Outcome Measures

Primary Outcomes (3)

• 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%

• 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%

• 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 Outcomes (4)

• ejection fraction (EF)

  after 10 min exposure to sevoflrane 1.0vol%, 2.0 vol% and 3.0 vol%

• bispectral index (BIS)

  after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%

• 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%

• 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%

Study Arms (1)

sevoflurane

EXPERIMENTAL

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

Drug: Sevoflurane dosage titration

Interventions

Sevoflurane dosage titration DRUG

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)

Also known as: sevorane

sevoflurane

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 143-729, South Korea

Location

Related 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. doi: 10.1016/S0894-7317(03)00634-5.

  PMID: 14566295 BACKGROUND

• 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.

  PMID: 11734780 BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Tae-Yop Kim, MD PhD

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 19, 2012
• Study Start: May 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

KR (1)