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

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05033041
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
29.4
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Study drug metoclopramide
  • Drug: Study drug placebo administration
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled blinded studyRandomized controlled blinded study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Research pharmacy to prepare the study medication blinding the participant, care providers, investigator and outcomes assessor.
Primary Purpose:
Treatment
Official Title:
Comparison of Gastric Volumes by Gastric Ultrasound in Term Parturients Undergoing Scheduled Elective Cesarean Delivery With and Without Metoclopramide
Actual Study Start Date :
Oct 20, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1 Study Drug Metoclopramide

Intravenous administration of 10 mg metoclopramide

Drug: Study drug metoclopramide
Intravenous administration of 4 mg metoclopramide
Placebo Comparator: Group 2 Study Drug Placebo

Intravenous administration of sterile normal saline

Drug: Study drug placebo administration
Intravenous administration of placebo (sterile normal saline)

Outcome Measures

Primary Outcome Measures

  1. Change in gastric volume (mL) [30 minutes after administration of study drug]

    Change in gastric volume (mL) determined by ultrasound before and 30 minutes after administration of study drug

Secondary Outcome Measures

  1. Incidence (number of events) of nausea and vomiting [24 hours]

    Number of episodes (events) of intraoperative nausea and vomiting during cesarean delivery and post-operative nausea and vomiting after cesarean delivery (correlated to metoclopramide administration and gastric volume)

  2. Adverse events [48 hours]

    Number of adverse events (akathisia, dystonia, abdominal cramping, extrapyramidal symptoms) experienced between the two study groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern Memorial Hospital and Prentice Women's Hospital Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Jennifer Banayan, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jennifer Banayan, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier:
NCT05033041
Other Study ID Numbers:
  • STU00215570
First Posted:
Sep 2, 2021
Last Update Posted:
Oct 29, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jennifer Banayan, Principal Investigator, Northwestern University
Pregnancy
Gastric Volume
Ultrasound Measurement
Aspiration Prevention
Cesarean Section
Additional relevant MeSH terms:
Metoclopramide

Study Results

No Results Posted as of Oct 29, 2021