This Study Was Focused to Evaluate Feasibility of Doppler Tissue Monitoring During the Induction Anesthesia,NCT02408341
Propofol Induction's Effect on Cardiac Function
An observational study of This Study Was Focused to Evaluate Feasibility of Doppler Tissue Monitoring During the Induction Anesthesia, and and Evaluate Routine Propofol Induction's Effect on Myocardial Tissue Motion, Using Non-invasive Doppler Tissue and 2D Speckle Tracking Imaging., run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Background: Propofol effects dose-dependent myocardial depression, but there is little clinical data available regarding the direct impact of propofol induction on myocardial function. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- This Study Was Focused to Evaluate Feasibility of Doppler Tissue Monitoring During the Induction Anesthesia,, and Evaluate Routine Propofol Induction's Effect on Myocardial Tissue Motion, Using Non-invasive Doppler Tissue and 2D Speckle Tracking Imaging., This is the First Study, to Our Knowledge, Which Has Evaluated the Possible Impact of Propofol Induction on LV Function.
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population After approval by the institutional ethics committee and written informed consent, we prospectively enrolled adult patients who were scheduled for elective non-cardiac surgery. During the preoperative anesthesia visit, we selected patients with low-risk as indicated by the revised cardiac risk index of 0 and normal LV function (ejection fraction ≥ 60% and septal e' ≥ 8 cm/s. We excluded patients with an arrhythmia, poor lateral axis in supine position, regional wall motion abnormality, or other structural heart diseases. Patients with any of the following conditions were also excluded: unfavorable airway or facemask fit, intractable coughing, hiccups, or hypotension (mean BP < 60 mmHg) requiring IV positive inotropes or vasoconstrictors during the study period.
Who may be able to join
- Age over 18 years
- Non-cardiac surgery (already assigned)
- Low risk patients (RCRI score 0)
- Normal Left ventricular systolic function (ejection fraction >= 60%)
- Normal diastolic function (septal e' >= 8cm/s)
Who cannot join
- Poor echocardiographic imaging
- Emergency surgery
- Unstable hemodynamics (needs positive inotropics)
- Unfavorable airway or facemask
- Coughing, Hiccups
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Propofol Anesthesia Induction on Cardiac Function
Background: Propofol effects dose-dependent myocardial depression, but there is little clinical data available regarding the direct impact of propofol induction on myocardial function.
Objectives: The purpose of this study was to examine the impact of propofol-based anesthesia induction on cardiac function in low-risk patients.
Read the detailed description
Study population After approval by the institutional ethics committee and written informed consent, we prospectively enrolled adult patients who were scheduled for elective non-cardiac surgery. During the preoperative anesthesia visit, we selected patients with low-risk as indicated by the revised cardiac risk index of 0 and normal LV function (ejection fraction ≥ 60% and septal e' ≥ 8 cm/s). We excluded patients with an arrhythmia, poor lateral axis in supine position, regional wall motion abnormality, or other structural heart diseases. Patients with any of the following conditions were also excluded: unfavorable airway or facemask fit, intractable coughing, hiccups, or hypotension (mean BP < 60 mmHg) requiring IV positive inotropes or vasoconstrictors during the study period.
Anesthesia induction Upon each patient's arrival at the holding area, we placed an 18-gauge IV line in the right forearm vein and administered 10 mL/kg/hour of lactated Ringer's solution, 0.2 mg of glycopyrrolate, and 0.03 mg/kg of midazolam, as a premedication. Once in the operation room, we started to monitor electrocardiography, non-invasive BP, HR, pulse oximeter oxygen saturation, and the bispectral index (BIS). Anaesthesia induction was started in the following manner. Patients took a spontaneous respiration with inspired oxygen (8 L/min) through a transparent facemask and a circulation system with a reservoir bag. Bolus propofol (2.0 mg/kg) was administered intravenously for 10 seconds, after which assisted ventilation followed. After 5 minutes, complete induction was confirmed via a lack of train-of-four response and followed by tracheal intubation for maintenance anesthesia.
Intraoperative transthoracic echocardiography: Imaging After positioning the patient supine on the operation table, serial transthoracic echocardiography was performed with a portable GE Vivid Q platform (General Electric, Milwaukee, WI), before (T0) and 1, 3, and 5 minutes after the propofol bolus injection (T1, T2 and T3, respectively) along with hemodynamic recordings at the same time (BP, HR, and BIS). Two-dimensional imaging of parasternal and apical views and pulsed wave (PW) Doppler imaging of mitral inflow \& LV outflow were performed. DTI was recorded at both septal and lateral mitral annulus from the apical 4-chamber view to determine longitudinal endocardial velocities with a sweep of 66.7 mm/s. Each set of images required less than 30 seconds.
- Conditions
- This Study Was Focused to Evaluate Feasibility of Doppler Tissue Monitoring During the Induction Anesthesia,, and Evaluate Routine Propofol Induction's Effect on Myocardial Tissue Motion, Using Non-invasive Doppler Tissue and 2D Speckle Tracking Imaging., This is the First Study, to Our Knowledge, Which Has Evaluated the Possible Impact of Propofol Induction on LV Function.
- Keywords
- Propofol, Induction anesthesia, Doppler tissue imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Routine clinical practice of induction anesthesia | There was no intervention, just monitoring of clinical routine practice using non-invasive Doppler tissue imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of more than 20% difference of Doppler myocardial tissue systolic motion after propofol administration
Anesthesia was induced by intravenous propofol (2.0 mg/kg). We measured tissue Doppler-derived indexes of systolic myocardial motion (S') before and then 1, 3, and 5 minutes after propofol administration. We compared the serial changes by repeated measures ANOVA with Bonferroni post-hoc analyses. More than 20% reduction considered clinically relevant.
Measured: 1minute, 3 minutes, 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Was Focused to Evaluate Feasibility of Doppler Tissue Monitoring During the Induction Anesthesia,Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Suk Yang, MD, PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408341
- Sponsor's protocol ID
- KonkukUMC-2012-01
- Status last verified
- Mar 2015
- First submitted
- 31 Mar 2015
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Propofol Anesthesia Induction on Cardiac Function
- ClinicalTrials.gov ID
- NCT02408341
- Acronym / sponsor ID
- KonkukUMC-2012-01
- Conditions
- This Study Was Focused to Evaluate Feasibility of Doppler Tissue Monitoring During the Induction Anesthesia,, and Evaluate Routine Propofol Induction's Effect on Myocardial Tissue Motion, Using Non-invasive Doppler Tissue and 2D Speckle Tracking Imaging., This is the First Study, to Our Knowledge, Which Has Evaluated the Possible Impact of Propofol Induction on LV Function.
- Keywords
- Propofol, Induction anesthesia, Doppler tissue imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Propofol effects dose-dependent myocardial depression, but there is little clinical data available regarding the direct impact of propofol induction on myocardial function.
Objectives: The purpose of this study was to examine the impact of propofol-based anesthesia induction on cardiac function in low-risk patients.
Detailed description
Study population After approval by the institutional ethics committee and written informed consent, we prospectively enrolled adult patients who were scheduled for elective non-cardiac surgery. During the preoperative anesthesia visit, we selected patients with low-risk as indicated by the revised cardiac risk index of 0 and normal LV function (ejection fraction ≥ 60% and septal e' ≥ 8 cm/s). We excluded patients with an arrhythmia, poor lateral axis in supine position, regional wall motion abnormality, or other structural heart diseases. Patients with any of the following conditions were also excluded: unfavorable airway or facemask fit, intractable coughing, hiccups, or hypotension (mean BP < 60 mmHg) requiring IV positive inotropes or vasoconstrictors during the study period.
Anesthesia induction Upon each patient's arrival at the holding area, we placed an 18-gauge IV line in the right forearm vein and administered 10 mL/kg/hour of lactated Ringer's solution, 0.2 mg of glycopyrrolate, and 0.03 mg/kg of midazolam, as a premedication. Once in the operation room, we started to monitor electrocardiography, non-invasive BP, HR, pulse oximeter oxygen saturation, and the bispectral index (BIS). Anaesthesia induction was started in the following manner. Patients took a spontaneous respiration with inspired oxygen (8 L/min) through a transparent facemask and a circulation system with a reservoir bag. Bolus propofol (2.0 mg/kg) was administered intravenously for 10 seconds, after which assisted ventilation followed. After 5 minutes, complete induction was confirmed via a lack of train-of-four response and followed by tracheal intubation for maintenance anesthesia.
Intraoperative transthoracic echocardiography: Imaging After positioning the patient supine on the operation table, serial transthoracic echocardiography was performed with a portable GE Vivid Q platform (General Electric, Milwaukee, WI), before (T0) and 1, 3, and 5 minutes after the propofol bolus injection (T1, T2 and T3, respectively) along with hemodynamic recordings at the same time (BP, HR, and BIS). Two-dimensional imaging of parasternal and apical views and pulsed wave (PW) Doppler imaging of mitral inflow \& LV outflow were performed. DTI was recorded at both septal and lateral mitral annulus from the apical 4-chamber view to determine longitudinal endocardial velocities with a sweep of 66.7 mm/s. Each set of images required less than 30 seconds.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine clinical practice of induction anesthesia | – | –There was no intervention, just monitoring of clinical routine practice using non-invasive Doppler tissue imaging. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population After approval by the institutional ethics committee and written informed consent, we prospectively enrolled adult patients who were scheduled for elective non-cardiac surgery. During the preoperative anesthesia visit, we selected patients with low-risk as indicated by the revised cardiac risk index of 0 and normal LV function (ejection fraction ≥ 60% and septal e' ≥ 8 cm/s. We excluded patients with an arrhythmia, poor lateral axis in supine position, regional wall motion abnormality, or other structural heart diseases. Patients with any of the following conditions were also excluded: unfavorable airway or facemask fit, intractable coughing, hiccups, or hypotension (mean BP < 60 mmHg) requiring IV positive inotropes or vasoconstrictors during the study period.
Key inclusion criteria (5 listed)
- Age over 18 years
- Non-cardiac surgery (already assigned)
- Low risk patients (RCRI score 0)
- Normal Left ventricular systolic function (ejection fraction >= 60%)
- Normal diastolic function (septal e' >= 8cm/s)
Key exclusion criteria (5 listed)
- Poor echocardiographic imaging
- Emergency surgery
- Unstable hemodynamics (needs positive inotropics)
- Unfavorable airway or facemask
- Coughing, Hiccups
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of more than 20% difference of Doppler myocardial tissue systolic motion after propofol administration
Time frame: 1minute, 3 minutes, 5 minutes
Anesthesia was induced by intravenous propofol (2.0 mg/kg). We measured tissue Doppler-derived indexes of systolic myocardial motion (S') before and then 1, 3, and 5 minutes after propofol administration. We compared the serial changes by repeated measures ANOVA with Bonferroni post-hoc analyses. More than 20% reduction considered clinically relevant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of This Study Was Focused to Evaluate Feasibility of Doppler Tissue Monitoring During the Induction Anesthesia, and and Evaluate Routine Propofol Induction's Effect on Myocardial Tissue Motion, Using Non-invasive Doppler Tissue and 2D Speckle Tracking Imaging., run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of more than 20% difference of Doppler myocardial tissue systolic motion after propofol administration (time frame: 1minute, 3 minutes, 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.