Influence of Diastolic Performance on the Response to Norepinephrine for Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery and Fetal Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Indexed Cardiac Output
研究概览
简要总结
Background and rationale: The best agent to prevent spinal-induced hypotension is still uncertain but norepinephrine showed fewer effects on heart rate and cardiac output. In septic patients norepinephrine has been shown to produce an "endogenous fluid challenge".
Objective: We aim to assess if patients with impaired diastolic function (46% of pregnant women at term) are less able to maintain indexed cardiac output in response to norepinephrine infusion during spinal-induced vasoplegia. We also aim to assess if fetal wellbeing is related to maternal cardiac output during spinal anesthesia for cesarean delivery.
Methods: We will assess by echocardiogram the diastolic function before surgery and will then start continuous non-invasive hemodynamic monitoring with a ClearSight® monitor (ClearSight®, Edwards Lifescience, Irvine, CA) and perform a fluid challenge to relate diastolic disfunction with fluid responsiveness. Hemodynamic monitoring will continue throughout the surgery. Norepinephrine infusion will start concomitantly to beginning of spinal anesthesia and will stop 5 minutes after uterotonic medication.
Outcome: We aim to assess if patients with diastolic disfunction are less able to maintain cardiac output in response to norepinephrine infusion during spinal anesthesia induced vasoplegia. We also aim to assess if fetal wellbeing is related to maternal cardiac output during spinal anesthesia for cesarean delivery.)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women between the 36th and the 40th week of gestation undergoing spinal anesthesia for elective caesarian delivery.
排除标准
- •age < 18 yo;
- •preeclampsia;
- •atrial fibrillation and sinus tachycardia;
- •cardiovascular diseases;
- •neuromuscular disease;
- •emergent or urgent cesarean delivery;
- •coagulopathies;
- •contraindications to spinal anesthesia.
研究组 & 干预措施
Normal Diastolic Function
Diastolic Function within normal values (defined in terms of E wave and A wave velocity and Deceleration Time according to the American Society of Echocardiography and the European Association of Echocardiography)
干预措施: Norepinephrine (Drug)
Normal Diastolic Function
Diastolic Function within normal values (defined in terms of E wave and A wave velocity and Deceleration Time according to the American Society of Echocardiography and the European Association of Echocardiography)
干预措施: ClearSight®, Edwards Lifescience, Irvine, CA (Device)
Impaired Diastolic Function
Diastolic Function with pseudonormal pattern or impaired values (defined in terms of E wave and A wave velocity and Deceleration Time according to the American Society of Echocardiography and the European Association of Echocardiography)
干预措施: Norepinephrine (Drug)
Impaired Diastolic Function
Diastolic Function with pseudonormal pattern or impaired values (defined in terms of E wave and A wave velocity and Deceleration Time according to the American Society of Echocardiography and the European Association of Echocardiography)
干预措施: ClearSight®, Edwards Lifescience, Irvine, CA (Device)
结局指标
主要结局
Indexed Cardiac Output
时间窗: Baseline/after spinal anesthesia/after delivery
We aim to study if the diastolic performance of the heart measured by transthoracic echocardiography in healthy pregnant women at term undergoing spinal anesthesia for caesarean delivery influences the effects of norepinephrine on indexed cardiac output (CI) measured by non-invasive continuous hemodynamic monitoring.
次要结局
- Indexed Stroke Volume(Baseline/after spinal anesthesia/after delivery)
- Heart Rate(Baseline/after spinal anesthesia/after delivery)
- Systolic Blood Pressure(Baseline/after spinal anesthesia/after delivery)
- Apgar Scores(Decreases of Indexed Cardiac Output after spinal anesthesia)
研究者
SONNINO CHIARA
Registered Anesthesiologist
Fondazione Policlinico Universitario Agostino Gemelli IRCCS