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OpenTrials
Completed

NCT Number: NCT02408341

Propofol Induction's Effect 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Effect of Intravenous Propofol Anesthesia Induction on Cardiac Function

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 3, 2015
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.