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NCT Number: NCT06789614

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

About this study

Patients undergoing bariatric surgery report significant postoperative nausea and vomiting (PONV), which contributes to delayed oral intake and mobilization with a subsequent prolonged hospital length of stay. (1) The high incidence of PONV after bariatric surgery is referred to several factors such as obesity, prevalence of hiatal hernia, direct gastric irritation by surgical trauma, blood, and secretions, abdominal insufflation, increased surgical duration of > 1 hour, and the use of opioids. (2,3) The latest consensus guidelines for prophylaxis against PONV recommended the use of > 2 prophylactic drugs in patients with > 2 risk factors for PONV (4). A considerable proportion of patients undergoing bariatric surgery have > 2 risk factors (laparoscopic bariatric procedure - young age - non-smokers - opioid use). The first and second lines for prophylaxis are commonly 5HT-3 antagonist (e.g., ondansetron) and dexamethasone. However, there is no clear evidence for the superiority of either of the 3rd line drugs over the other. Several groups of drugs are suggested as 3rd line drugs such as dopamine receptor antagonists (e.g., metoclopramide) (5) ; histamine antagonists (e.g., prochlorperazine and Cyclizine) (6) , anticholinergics (such as scopolamine) (7) and neurokinin antagonists (such as Fosaprepitant) (8) .

Metoclopramide acts centrally by blocking dopamine receptors in the CTZ and vomiting centre and peripherally by shortening bowel transit time and in high doses blocks serotonin receptors. (9) Cyclizine is a piperazine derivative. It is an antihistamine i.e (H1)- receptor antagonist, and also has some effect on the dopamine (D2) and cholinergic receptors and inhibits integrative function of the vestibular nuclei. (10,11) measurement of the Gastric residual volume (GRV) has been widely used in perioperative medicine the last few years especially with the increased interest in point-of-care ultrasound. GRV is a predictor of PONV (12). Furthermore, several reports used GRV as an index of the prokinetic efficiency of antiemetic drugs (13,14) The aim of this study is to evaluate the effects of metoclopramide versus Cyclizine, within the context of multimodal antiemetic strategy, on GRV in patients scheduled for bariatric surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ● 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.

Exclusion criteria

  • ● 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.

Treatment and study plan

intravenous CYCLIZINE ,Metaclopromide

Drug

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

Primary outcomes

  1. Estimated Gastric volume (mL)

    Time frame: 1 hour after administration of the study drugs

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

Secondary outcomes

  1. ● Incidence of PONV

    Time frame: 24 hours

    ● Incidence of PONV in the 1st postoperative 24 hours (who receive the rescue antiemetic when the PONV grade reaches ≥ 2 or the 10_points Likert score reaches ≥ 4).

Study contacts

Contact information is provided by the study sponsor or research team.

fatema alzhraa Mohammed AlANANY, master

CONTACT

[email protected]

+201127642001 ext. +201277381131

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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