Propofol Induction's Effect on Cardiac Function

March 31, 2015 updated by: Hyun Suk Yang, MD, PhD, Konkuk University Medical Center

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Poor echocardiographic imaging
  • Emergency surgery
  • Unstable hemodynamics (needs positive inotropics)
  • Unfavorable airway or facemask
  • Coughing, Hiccups

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Routine clinical practice of induction anesthesia
There was no intervention, just monitoring of clinical routine practice using non-invasive Doppler tissue imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1minute, 3 minutes, 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • KonkukUMC-2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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