Bariatric SurgeryNCT06789614
Comparison of the Effect of Cyclizine Versus Metoclopramide on Gastric Residual Volume in Patients Undergoing Bariatric Surgery: A Randomized Double-blinded Clinical Trial
An observational study of Bariatric Surgery, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- intravenous CYCLIZINE ,Metaclopromide
- Type of treatment
- Injection or infusion
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 18 Feb 2025to 18 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: morbidely obese ASA2-3
Who may be able to join
- ● 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.
Who cannot join
- ● 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
fatema alzhraa Mohammed AlANANY, master contact
About this study
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.
Read the detailed description
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.
- Conditions
- Bariatric Surgery
- Being tested
- intravenous CYCLIZINE ,Metaclopromide
- Keywords
- GRV, Bariatric Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous CYCLIZINE ,MetaclopromideDrug
US giuded measure of GRV in bariatrics surgery upon recieving drugs of study
| Study group | Role | What they receive |
|---|---|---|
| Cyclizine group | will receive intravenous Cyclizine (50 mg) in a 10 mL syringe. Receives: Drug: intravenous CYCLIZINE ,Metaclopromide | |
| Metoclopramide group | participants will receive intravenous Metoclopramide (10 mg) in a (10 mL )syringe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after administration of the study drugs
Secondary outcomes (1)
● Incidence of PONV
● 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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start18 Feb 2025 (estimated)
- Primary completion18 Sep 2025 (estimated)
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatema alzhraa Mohammed mohammadeen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789614
- Sponsor's protocol ID
- GRS in bariatric surgery
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Cyclizine Versus Metoclopramide on Gastric Residual Volume in Patients Undergoing Bariatric Surgery: A Randomized Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT06789614
- Acronym / sponsor ID
- GRS in bariatric surgery
- Conditions
- Bariatric Surgery
- Keywords
- GRV, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Feb 2025 (estimated)
- Primary completion
- 18 Sep 2025 (estimated)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclizine group | – | Drug: intravenous CYCLIZINE ,Metaclopromidewill receive intravenous Cyclizine (50 mg) in a 10 mL syringe. |
| Metoclopramide group | – | –participants will receive intravenous Metoclopramide (10 mg) in a (10 mL )syringe. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- morbidely obese ASA2-3
Key inclusion criteria (5 listed)
- ● Age (18 - 40).
Key exclusion criteria (9 listed)
- ● Refusal of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous CYCLIZINE ,MetaclopromideUS giuded measure of GRV in bariatrics surgery upon recieving drugs of study | Drug | Cyclizine group |
Primary outcome
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.
1 secondary outcome
● Incidence of PONV
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgery
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
Lifestyle Adherence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
fatema alzhraa Mohammed AlANANY, master contact
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact fatema alzhraa Mohammed AlANANY, master (+201127642001 ext. +201277381131, fatemaalzhraa.moh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Gastric volume (mL) (time frame: 1 hour after administration of the study drugs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.