Transthoracic Echocardiographic Monitoring of Cardiac Output Effects of Colloid Preload and Crystalloid Coload During Cesarean Delivery Under Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sameh Fathy
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Changes in Cardiac Output
研究概览
简要总结
Transthoracic echocardiography (TTE) has been introduced in anesthesia and intensive care practice to assess the volume status and predict fluid responsiveness, with a few studies performed on pregnant women (5).
In this study, we aim to evaluate the effect of intravenous administration of albumin as a colloid preload on the maternal stroke volume (SV) and cardiac output (CO) versus crystalloid coload. We used TTE to measure the changes in SV, and CO at baseline and at subsequent time points after spinal anesthesia.
详细描述
This prospective randomized controlled, double-blind study will be conducted at the obstetrics and gynecology operation room, at Qassim University Medical City.
Written informed consent will be obtained from eligible subjects on the day of the surgery. The study subjects will be randomized using the R software, version 3.5.2 (R Core Team, 2018; R Foundation for Statistical Computing, Vienna, Austria). Subjects will randomly be assigned to 2 equal groups (combined and crystalloid coload) using the permuted block randomization method with randomly selected block sizes of 4 and 6. The group allocation codes will be hidden in sequentially numbered, opaque, sealed envelopes that will be opened only after assessing the eligibility and obtaining the consent from the subjects. The study subjects and the outcome assessors will be blinded to the study group.
Spinal anesthesia will be conducted will be assessed respectively by an anesthesiologist not involved in the study.
All transthoracic cardiography images will be obtained by the second investigator who have the experience of accomplishing > 500 cases before starting the study using the technique and guidelines reported in American Society of Echocardiography . During obtaining the images intraoperatively, the investigator will be separated from the surgical field by a sterile drape, and the ultrasound probe will be covered with a sterile cover.
The study subjects will enter the operating room, lying supine on the operating table with slight left lateral position by tilting the operating table to the left. Standard monitors will be attached to all patients (noninvasive blood pressure, pulse oximeter, and electrocardiography). Basal systolic blood pressure and heart rate will be recorded after a period of rest, the average of 3 readings, 2 minutes apart will be recorded. Basal transthoracic cardiography images will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists physical status II parturients with full term singleton pregnancies scheduled for elective cesarean delivery under spinal anesthesia.
排除标准
- •Height <150 cm, weight <55 kg, and body mass index ≥40 kg/m
- •Women presenting in labor or having any contraindication to spinal anesthesia (patient refusal, increased intracranial pressure, coagulation disorders, or local skin infection).
- •Chronic or pregnancy-induced hypertension; baseline systolic blood pressure >140 mm Hg.
- •Hemoglobin <10 g/dL.
- •Diabetes mellitus.
- •Cardiovascular, cerebrovascular, or renal disease.
- •Polyhydramnios or fetal abnormalities.
研究组 & 干预措施
Crystalloid group
Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output.
Patients will receive 1000 mL of Ringer's lactate solution over 15 minutes.
干预措施: Transthoracic Echocardiography (Device)
Crystalloid group
Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output.
Patients will receive 1000 mL of Ringer's lactate solution over 15 minutes.
干预措施: Ringer lactate 1000 ml (Drug)
Combination group
Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output.
Patients will receive 250 mL of human albumin 5% over 10 minutes and 750 mL of Ringer's lactate solution over 15 minutes.
干预措施: Transthoracic Echocardiography (Device)
Combination group
Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output.
Patients will receive 250 mL of human albumin 5% over 10 minutes and 750 mL of Ringer's lactate solution over 15 minutes.
干预措施: Albumin (Drug)
Combination group
Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output.
Patients will receive 250 mL of human albumin 5% over 10 minutes and 750 mL of Ringer's lactate solution over 15 minutes.
干预措施: Ringer lactate 750 ml (Drug)
结局指标
主要结局
Changes in Cardiac Output
时间窗: Immediately after delivery of baby
The changes in Cardiac Output are measured relative to baseline immediately after delivery
次要结局
- Changes in stroke volume(Immediately after delivery of baby)
- Total phenylephrine dose (mg)(Until delivery of baby)
- Total ephedrine dose (mg)(Until delivery of the baby)
- Total glycopyrrolate dose (mg)(Until delivery of the baby)
- Incidence of hypotension(Until end of surgery)
- Incidence of bradycardia(Until end of surgery)
- Incidence of nausea and/or vomiting(Until end of surgery)
- Measurement of APGAR score(1 minute and 5 minutes after delivery of the baby)
- Measurement of Urine output (ml)(1 hour after delivery of the baby)
研究者
Sameh Fathy
Assistant Professor of Anesthesia and ICU - Faculty of Medicine - Mansoura University
Mansoura University