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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Intravenous administration of 10 mg metoclopramide
Intravenous administration of placebo (sterile normal saline)
Northwestern Memorial Hospital and Prentice Women's Hospital
Chicago, Illinois, United States
Change in Gastric Volume (mL)
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.
Time frame: 30 minutes after administration of study drug
Subject Report of Nausea During Cesarean Section
Subject reported intraoperative nausea during the cesarean delivery
Time frame: 24 hours
Adverse Events
Number of reported adverse events experienced for each group.
Time frame: 72 hours
Intraoperative Nausea Occurrences
Number of nausea occurrences during cesarean section procedure
Time frame: 24 hours
Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes
Total elapsed time in minutes from the placement of the intrathecal medications by anesthesiology team to the first experience of nausea reported by the participant.
Time frame: 24 hours
Subject Experienced Vomiting During Cesarean Section
Subject experienced vomiting episode during the cesarean delivery procedure.
Time frame: 24 Hours
Number of Intraoperative Vomiting Occurrences
Number of intraoperative vomiting occurrences during the cesarean section.
Time frame: 24 Hours
Time From Intrathecal Anesthesia to Vomiting Episode in Minutes.
The elapsed time in minutes from anesthesia team placing the intrathecal medications to the first episode of vomiting during.
Time frame: 24 Hours
Antiemetic Prophylaxis
Subject received antiemetic prophylaxis of ondansetron or dexamethasone prior to the cesarean section.
Time frame: 24 Hours
PACU Antiemetic Treatment (n)
Number of participants who required antiemetic medications in the post anesthesia care unit
Time frame: 24 hours
Nausea After PACU Discharge
Number of participants who experienced nausea after being discharged from the post anesthesia care unit
Time frame: 72 hours
Elapsed Time From Study Drug to Second Ultrasound
Total elapsed time in minutes after study drug administered to second gastric ultrasound.
Time frame: 24 hours
Second Ultrasound Cross Sectional Area (cm^2)
The cross sectional area in centimeters squared for the second gastric ultrasound which was performed 30 minutes after study medication administered
Time frame: 24 hours
Post Treatment Estimated Volume (mL) Second Ultrasound
Gastric volume in milliliters of the second ultrasound obtained 30 minutes after study drug administration
Time frame: 24 hours
Second Ultrasound Volume >1.5 * Weight (kg)
Number of subjects experiencing a volume greater than than 1.5 times weight in kilograms after the second gastric ultrasound 30 minutes after study medication administration.
Time frame: 24 hours
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