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

Northwestern University

Status and phase: Completed; Phase 4

Conditions: Cesarean Section; Aspiration; Pregnancy

Treatments: Drug: Study drug placebo administration; Drug: Study drug metoclopramide

Study type: Interventional

Funder types: Other

Identifiers

NCT05033041

STU00215570

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Group 1 Study Drug Metoclopramide

Active Comparator group

Description:

Intravenous administration of 10 mg metoclopramide

Treatment:

Drug: Study drug metoclopramide

Group 2 Study Drug Placebo

Placebo Comparator group

Description:

Intravenous administration of sterile normal saline

Treatment:

Drug: Study drug placebo administration