Clinical trial NCT05033041: Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide
Official title: Comparison of Gastric Volumes by Gastric Ultrasound in Term Parturients Undergoing Scheduled Elective Cesarean Delivery With and Without Metoclopramide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Cesarean Section
Aspiration
Keywords: Pregnancy
Gastric Volume
Ultrasound Measurement
Aspiration Prevention
Cesarean Section
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled blinded study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Gastric Volume (mL)
timeFrame: 30 minutes after administration of study drug
Secondary outcomes:
measure: Subject Report of Nausea During Cesarean Section
timeFrame: 24 hours
measure: Adverse Events
timeFrame: 72 hours
measure: Intraoperative Nausea Occurrences
timeFrame: 24 hours
measure: Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes
timeFrame: 24 hours
measure: Subject Experienced Vomiting During Cesarean Section
timeFrame: 24 Hours
measure: Number of Intraoperative Vomiting Occurrences
timeFrame: 24 Hours
measure: Time From Intrathecal Anesthesia to Vomiting Episode in Minutes.
timeFrame: 24 Hours
measure: Antiemetic Prophylaxis
timeFrame: 24 Hours
measure: PACU Antiemetic Treatment (n)
timeFrame: 24 hours
measure: Nausea After PACU Discharge
timeFrame: 72 hours
measure: Elapsed Time From Study Drug to Second Ultrasound
timeFrame: 24 hours
measure: Second Ultrasound Cross Sectional Area (cm^2)
timeFrame: 24 hours
measure: Post Treatment Estimated Volume (mL) Second Ultrasound
timeFrame: 24 hours
measure: Second Ultrasound Volume >1.5 * Weight (kg)
timeFrame: 24 hours
Other outcomes:
measure: First Ultrasound Stomach Cross-sectional Area (cm2)
timeFrame: After consent obtained
measure: First Ultrasound Volume Greater Than 1.5 * Weight (kg)
timeFrame: After consent obtained
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital and Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jennifer Banayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
citation: MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available.
citation: Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
citation: 4. Knight M, Bunch K, Tuffnell D, Shakespeare J, Kotnis R, Kenyon S, Kurinczuk JJ (Eds.) on behalf of MBRRACE-UK. Saving Lives, Improving Mothers' Care - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2016-18. Oxford: National Perinatal Epidemiology Unit, University of Oxford 2020.
citation: Leus M, van de Ven A. IMAGES IN CLINICAL MEDICINE. An Acute Dystonic Reaction after Treatment with Metoclopramide. N Engl J Med. 2015 Oct;373(14):e16. doi: 10.1056/NEJMicm1412207. No abstract available.
citation: Mishriky BM, Habib AS. Metoclopramide for nausea and vomiting prophylaxis during and after Caesarean delivery: a systematic review and meta-analysis. Br J Anaesth. 2012 Mar;108(3):374-83. doi: 10.1093/bja/aer509. Epub 2012 Feb 3.
citation: Paranjothy S, Griffiths JD, Broughton HK, Gyte GM, Brown HC, Thomas J. Interventions at caesarean section for reducing the risk of aspiration pneumonitis. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004943. doi: 10.1002/14651858.CD004943.pub3.
citation: Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.
citation: Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
citation: Arzola C, Perlas A, Siddiqui NT, Carvalho JCA. Bedside Gastric Ultrasonography in Term Pregnant Women Before Elective Cesarean Delivery: A Prospective Cohort Study. Anesth Analg. 2015 Sep;121(3):752-758. doi: 10.1213/ANE.0000000000000818.
citation: Arzola C, Perlas A, Siddiqui NT, Downey K, Ye XY, Carvalho JCA. Gastric ultrasound in the third trimester of pregnancy: a randomised controlled trial to develop a predictive model of volume assessment. Anaesthesia. 2018 Mar;73(3):295-303. doi: 10.1111/anae.14131. Epub 2017 Dec 19.