Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide

Phase 4

Completed

Conditions: Pregnancy
Cesarean Section
Aspiration

Interventions: Drug: Study drug metoclopramide
Drug: Study drug placebo administration

Registration Number: NCT05033041

Lead Sponsor: Northwestern University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 Study Drug Metoclopramide	Study drug metoclopramide	Intravenous administration of 10 mg metoclopramide
Group 2 Study Drug Placebo	Study drug placebo administration	Intravenous administration of sterile normal saline

Primary Outcome Measures

Name	Time	Method
Change in Gastric Volume (mL)	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.

Secondary Outcome Measures

Name	Time	Method
Intraoperative Nausea Occurrences	24 hours	Number of nausea occurrences during cesarean section procedure
PACU Antiemetic Treatment (n)	24 hours	Number of participants who required antiemetic medications in the post anesthesia care unit
Nausea After PACU Discharge	72 hours	Number of participants who experienced nausea after being discharged from the post anesthesia care unit
Elapsed Time From Study Drug to Second Ultrasound	24 hours	Total elapsed time in minutes after study drug administered to second gastric ultrasound.
Subject Report of Nausea During Cesarean Section	24 hours	Subject reported intraoperative nausea during the cesarean delivery
Adverse Events	72 hours	Number of reported adverse events experienced for each group.
Number of Intraoperative Vomiting Occurrences	24 Hours	Number of intraoperative vomiting occurrences during the cesarean section.
Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes	24 hours	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.
Subject Experienced Vomiting During Cesarean Section	24 Hours	Subject experienced vomiting episode during the cesarean delivery procedure.
Time From Intrathecal Anesthesia to Vomiting Episode in Minutes.	24 Hours	The elapsed time in minutes from anesthesia team placing the intrathecal medications to the first episode of vomiting during.
Antiemetic Prophylaxis	24 Hours	Subject received antiemetic prophylaxis of ondansetron or dexamethasone prior to the cesarean section.
Second Ultrasound Cross Sectional Area (cm^2)	24 hours	The cross sectional area in centimeters squared for the second gastric ultrasound which was performed 30 minutes after study medication administered
Post Treatment Estimated Volume (mL) Second Ultrasound	24 hours	Gastric volume in milliliters of the second ultrasound obtained 30 minutes after study drug administration
Second Ultrasound Volume >1.5 * Weight (kg)	24 hours	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.