The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change from Baseline Systolic Blood Pressure during cesarean section
研究概览
简要总结
The purpose of this study is to compare the administration of two different doses of ondansetron to placebo to prevent hypotension and bradycardia following spinal anaesthesia. Apart from haemodynamic parameters (blood pressure and heart rate),characters of the spinal blockage (time of onset and regression) will be recorded too.
详细描述
The day before surgery the procedure will be explained to the patient and the written consent will be obtained. In the operating room, intraoperative monitoring will include electrocardiography (ECG), noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). Two peripheral intravenous catheters wil be placed for fluid replacement and administration of drugs.
Participants will be randomly assigned to one of the following groups:
Group A: Women will receive 4 milligrams (mg) of ondansetron diluted in 100 milliliters (ml) of normal saline 0.9 percent 10 minutes before spinal anaesthesia
Group B:Women will receive 8 mg of ondansetron diluted in 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia
Group C:Women will receive 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All solutions will be prepared by an independent researcher who will not be further involved in the study eg data collecting or analyzing them. All solutions will look identical to the anesthetist who will administer them to the patients.Apart from the anesthetist, the surgery staff and the researchers recording the measurements will not know the therapeutic intervention team in which each patient has been randomized.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Physical status according to American Society of Anesthesiologists (ASA) I-II
- •Singleton pregnant women in full term pregnancy
- •Patients scheduled for cesarean section
- •Height 158cm-170cm
排除标准
- •patient's own refusal
- •contraindications to spinal anesthesia (coagulation disorders, inflammation at the puncture site, allergy to local anesthetics)
- •ondansetron allergy
- •body mass index> 33kg / m^2
- •height <158cm, or> 170cm
- •hypertensive disorders of pregnancy
- •cardiovascular disease
- •receiving selective serotonin reuptake inhibitors (SSRI's) or treatment for migraine
- •placenta previa.
研究组 & 干预措施
Group A
Intravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
干预措施: Ondansetron 4mg (Drug)
Group B
Intravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
干预措施: Ondansetron 8mg (Drug)
Group C
Intravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
干预措施: 100ml normal saline 0.9 percent (Drug)
结局指标
主要结局
Change from Baseline Systolic Blood Pressure during cesarean section
时间窗: 60 minutes
every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery
Change from Baseline Heart Rate
时间窗: 60 minutes
every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery
次要结局
- Sensory blockade(20 minutes)
- Motor blockade(20 minutes)
- Sensory regression(120 minutes)
- Motor block regression(120 minutes)
- Time to maximum effect (Tmax)(20 minutes)
- Time to minimum effect (Tmin)(120 minutes)
- Nausea(0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively)
- Vomiting(0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively)
- Shivering(0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively)
- Total ephedrine consumption(60 minutes)
- Total phenylephrine consumption(60 minutes)
- Total atropine consumption(60 minutes)
- Umbilical cord ph(15 minutes)
- Need for administration of antiemetic agent(90 minutes)
- Neonate Apgar score(5 minutes)
研究者
Stavroula Karachanidi
Principal Investigator
Aretaieion University Hospital