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临床试验/NCT02408341
NCT02408341已完成不适用

Effect of Intravenous Propofol Anesthesia Induction on Cardiac Function

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Changes of more than 20% difference of Doppler myocardial tissue systolic motion after propofol administration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Changes of more than 20% difference of Doppler myocardial tissue systolic motion after propofol administration

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyun Suk Yang, MD, PhD

Assistant Professor, Cardiovascular Medicine

Konkuk University Medical Center

研究点 (1)

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