Effects on Ondansetron on Maternal Hemodynamics After Cesarean Section Under Spinal Anesthesia: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- hypotension
研究概览
简要总结
BACKGROUND:
Spinal anesthesia (SA) induced maternal hypotension is the most frequent and troublesome complication in cesarean section (CS), compromising both maternal and neonatal well-being. Many strategies have been used to prevent its occurrence but no single technique has been confirmed to be completely effective. the investigators hypothesized that ondansetron, a serotonin-receptor-antagonist, could have beneficial effects on maternal hemodynamics during CS under SA.
METHODS:
In this prospective double-blind placebo-controlled study, one hundred healthy parturients were randomized to receive either 8 mg of intravenous ondansetron (group O) or the same volume of saline (group S), 5 minutes prior to the induction of SA. All women received a coloading volume of 500 ml of saline. Maternal hemodynamics: blood pressure, heart rate and cardiac output (CO) were measured with a non-invasive device based on pulse wave transit time: the esCCO device Nihon Kohden hemodynamic monitor. Ephedrine was administered to treat hypotension (systolic blood pressure less than 80% of baseline).
详细描述
- Type of the study:
After institutional ethical committee approval, we conducted a prospective double-blind, placebo-controlled, randomized study, at the department of anesthesiology of the Mahdia's university hospital, from August to November 2017. 2. Inclusion criteria:
Parturients eligible for the present study are women who:
are scheduled for elective cesarean section under spinal anesthesia. aged between 20 to 40 years. are with an American Society of Anesthesiologist (ASA) physical status of I-II are with a normal liver and renal function and fetal screening, and with no medical history of heart disease.
are with a single fetus. 3. Protocol description:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
an anesthesia nurse ; not included in the analysis, verified the allocation and prepared the syringe fulled with ondansetron or saline solution
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturients eligible for the present study are women who:
- •are scheduled for elective cesarean section under spinal anesthesia
- •aged between 20 to 40 years
- •are with an American Society of Anesthesiologist (ASA) physical status of I-II
- •are with a normal liver and renal function and fetal screening, and with no medical history of heart disease.
- •are with a single fetus.
排除标准
- •Refusal to participate.
- •Contraindication to spinal anesthesia
- •Age <20 or >40 years.
- •Obesity (body mass index (BMI) at term >35 kg/m2).
- •History of hypersensitivity to study's drugs.
- •History of long QT syndrome
- •Hypertensive disorders of pregnancy.
- •Women receiving selective serotonin reuptake inhibitors or migraine medications.
- •Urgent cesarean section.
- •Multiple pregnancies.
- •Failure of spinal anesthesia.
- •Conversion to general anesthesia.
- •The occurrence of an anesthetic or surgical complication.
研究组 & 干预措施
ondansetron group
Ondansetron 8Mg/4mL Injection: administration of a bolus of 8 mg intravenous Ondansetron diluted in 10 ml of saline solution (0,09%) 5 minutes before spinal anesthesia
干预措施: Ondansetron 8Mg/4mL Injection (Drug)
control group
administration of 10 ml of saline solution (0,09%) 5 minutes before spinal anesthesia
干预措施: Ondansetron 8Mg/4mL Injection (Drug)
结局指标
主要结局
hypotension
时间窗: 5 min after spinal anesthésia
decrease of systolic blood pressue with more than 25% from baseline values
次要结局
- escco(5 min after spinal anesthésia)
- ephedrine consumption(during 2 hours of anesthetic time)
研究者
Majdoub Ali MD
clinical professor
University Hospital, Mahdia