Comparison of Gastric Volumes by Gastric Ultrasound in Term Parturients Undergoing Scheduled Elective Cesarean Delivery With and Without Metoclopramide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Gastric Volume (mL)
研究概览
简要总结
Our objective is to compare gastric volumes (mL) between women who receive metoclopramide versus placebo prior to scheduled cesarean delivery in appropriately fasted patients. If metoclopramide is found not to reduce gastric volumes this would inform future practice guidelines for obstetric anesthesia, which currently recommends metoclopramide administration prior to cesarean deliveries.
We hypothesize that metoclopramide given to women with appropriate fasting prior to cesarean delivery does not result in any clinically significant reduction in gastric volume (mL) and therefore does not provide any additional benefit for aspiration prophylaxis but may expose patients to unnecessary side effects. A secondary objective will be to evaluate if gastric volume is a significant predictor of intraoperative nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Research pharmacy to prepare the study medication blinding the participant, care providers, investigator and outcomes assessor.
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
- •Healthy (ASA Physical Status 2)
- •Age >18 years old
- •Non-obese (BMI <40 kg/m2)
- •Age >18 years
- •Term (>37 week)
- •Non-laboring parturient
- •Single gestation
- •Scheduled for a cesarean delivery and NPO
排除标准
- •Systemic disease such as diabetes mellitus (type 1 or 2)
- •Multiple gestation
- •Abnormality of upper GI tract
- •History of GI tract related surgical procedures
- •Use of gastric motility medications
- •Active labor
- •Renal impairment (creatinine >2)
- •Non-English speaking
- •Cognitively impaired
- •History of QT prolongation
- •Use of general anesthesia
研究组 & 干预措施
Group 1 Study Drug Metoclopramide
Intravenous administration of 10 mg metoclopramide
干预措施: Study drug metoclopramide (Drug)
Group 2 Study Drug Placebo
Intravenous administration of sterile normal saline
干预措施: Study drug placebo administration (Drug)
结局指标
主要结局
Change in Gastric Volume (mL)
时间窗: 30 minutes after administration of study drug
Change in gastric volume (mL) determined by gastric ultrasound before and 30 minutes after administration of study drug. Gastric volumes were calculated from the cross sectional area (CSA) area using both the Perlas (Volume=27.0+14.6\*(RLD CSA (cm2)-1.28 \* age)) and the Roukhomovsky method (volume=(0.18\*RLD CSA (mm2))+(0.11\*SUP CSA (mm2)-62.4) methods.
次要结局
- Intraoperative Nausea Occurrences(24 hours)
- PACU Antiemetic Treatment (n)(24 hours)
- Nausea After PACU Discharge(72 hours)
- Elapsed Time From Study Drug to Second Ultrasound(24 hours)
- Subject Report of Nausea During Cesarean Section(24 hours)
- Adverse Events(72 hours)
- Number of Intraoperative Vomiting Occurrences(24 Hours)
- Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes(24 hours)
- Subject Experienced Vomiting During Cesarean Section(24 Hours)
- Time From Intrathecal Anesthesia to Vomiting Episode in Minutes.(24 Hours)
- Antiemetic Prophylaxis(24 Hours)
- Second Ultrasound Cross Sectional Area (cm^2)(24 hours)
- Post Treatment Estimated Volume (mL) Second Ultrasound(24 hours)
- Second Ultrasound Volume >1.5 * Weight (kg)(24 hours)
研究者
Jennifer Banayan
Principal Investigator
Northwestern University