Comparison of the Effect of Cyclizine Versus Metoclopramide on Gastric Residual Volume in Patients Undergoing Bariatric Surgery: A Randomized Double-blinded Clinical Trial

NCT06789614 | Not Yet Recruiting DMC

• 1 other identifier: GRS in bariatric surgery
• Study Type: observational
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this work is to compare the effects metoclopramide versus Cyclizine withing the context of multimodal antiemetic strategy on GRV in patients scheduled for bariatric surgery.

Conditions

Bariatric Surgery

Keywords

GRV, Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Estimated Gastric volume (mL)

  Estimated Gastric volume (mL) based on the antral CSA in the RLD (CSARLD) by gastric ultrasonic 1 hour after administration of the study drugs.

  1 hour after administration of the study drugs

Secondary Outcomes (1)

• ● Incidence of PONV

  24 hours

Study Arms (2)

Cyclizine group

will receive intravenous Cyclizine (50 mg) in a 10 mL syringe.

Drug: intravenous CYCLIZINE ,Metaclopromide

Metoclopramide group

participants will receive intravenous Metoclopramide (10 mg) in a (10 mL )syringe.

Interventions

intravenous CYCLIZINE ,Metaclopromide DRUG

US giuded measure of GRV in bariatrics surgery upon recieving drugs of study

Cyclizine group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

morbidely obese ASA2-3

You may qualify if:

• ● Age (18 - 40).
• Body mass index (BMI) 40 to 50 kg/m2.4
• American Society of Anaesthesiologist (ASA) - physical status III.
• Patients undergoing bariatric surgery.
• Non smokers.

You may not qualify if:

• ● Refusal of the patient
• Deviation from fasting times
• Patients with empty stomach
• Body mass index (BMI) less than 40s kg/m2
• American Society of Anesthesiologists (ASA) physical status class IV.
• Systemic diseases may cause delayed gastric emptying (eg: myopathies and myasthenia gravis).
• Patients with gastrointestinal diseases which impact the gastric emptying such as hiatus hernia, intestinal disease and gastro-oesophageal reflux disease and patients with history of upper gastrointestinal surgeries.
• Use of other medications known to affect gastric motility or secretions (Diphenoxylate, Atropine\& Imodium) or secretions.
• Allergy to macrolide or metoclopramide. • a considerable proportion of patients with obesity have diabetes and thus, they cannot be excluded from the study. However, we would exclude patients with long standing diabetes (more than 5 years) who are likely to have delayed gastric emptying. Furthermore, this is a randomized controlled trial and the randomization usually overcomes these points and the demographic data would be displayed in the results to clarify whether there is a balance between the two groups or not.

Sponsors & Collaborators

• Cairo University: lead

Related Links

• 1\. Celio A, Bayouth L, Burruss MB, Spaniolas K. Prospective assessment of postoperative nausea early after bariatric surgery. Obes Surg. 2019 Mar; 29(3):858- 861.
• Naeem Z, Chen IL, Pryor AD, Docimo S, Gan TJ, Spaniolas K. Antiemetic prophylaxis and anesthetic approaches to reduce postoperative nausea and vomiting in bariatric surgery patients: a systematic review. Obesity surgery. 2020 Aug;30:3188-200.
• 4\. Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC. Fourth consensus guidelines for the management of postoperative nausea and vomiting. Anesthesia \& Analgesia.

Central Study Contacts

fatema alzhraa Mohammed AlANANY, master

CONTACT

+201127642001; fatemaalzhraa.moh@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 18, 2025
• Primary Completion: September 18, 2025
• Study Completion: October 18, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share