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CataractNCT07086118

Dexamethasone Versus Metoclopramide for Prophylaxis of Nausea and Vomiting After Cataract Surgery

A study testing 0.9% normal saline, Metoclopramide 10mg and Dexamethasone in people with Cataract and Dexamethasone, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postoperative nausea and vomiting (PONV) is a common consequence of ambulatory surgery, affecting up to 80% of high-risk patients and 20-30% overall. Despite being widespread, a prior survey found that patients are more averse to PONV than pain and other significant postoperative problems. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Cataract, Dexamethasone
What is being tested?
0.9% normal saline, Metoclopramide 10mg and Dexamethasone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
1 siteEgypt
Study dates
1 May 2025to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 40-80 years, both sexes.
  • ASA physical status class I to III.
  • Apfel score 0-2

Who cannot join

  • history of motion sickness
  • patients with gastrointestinal disorders or gastro-oesophageal reflux
  • patients taking medications with known antiemetic activity
  • previous postoperative vomiting
  • allergy to bupivacaine
  • allergy to metoclopramide or dexamethasone

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Alexandria University

    Alexandria

Other trials in Egypt

About this study

Official title: Efficacy of Dexamethasone Versus Metoclopramide for Prophylaxis of Nausea and Vomiting After Cataract Surgery: A Double-blind Randomized Controlled Study

Postoperative nausea and vomiting (PONV) is a common consequence of ambulatory surgery, affecting up to 80% of high-risk patients and 20-30% overall. Despite being widespread, a prior survey found that patients are more averse to PONV than pain and other significant postoperative problems. Furthermore, even mild cases of PONV can have serious repercussions, such as postanesthesia care unit (PACU) workflow disruption, delayed discharges, higher medical costs, and lower patient satisfaction.PONV following intraocular surgery can be unpleasant and may lead to serious complications including suprachoroidal hemorrhage (SCH). SCH is a potentially serious condition that occurs when the posterior ciliary arteries or vortex veins burst, resulting in blood in the suprachoroidal region.

The hypothesis is that dexamethasone will lower the incidence of PONV after cataract surgery when compared with metoclopramide.

Read the detailed description

Postoperative nausea and vomiting (PONV) is a common consequence of ambulatory surgery, affecting up to 80% of high-risk patients and 20-30% overall.(1) Despite being widespread, a prior survey found that patients are more averse to PONV than pain and other significant postoperative problems.(2) Furthermore, even mild cases of PONV can have serious repercussions, such as postanesthesia care unit (PACU) workflow disruption, delayed discharges, higher medical costs, and lower patient satisfaction.(3)PONV following intraocular surgery can be unpleasant and may lead to serious complications including suprachoroidal hemorrhage (SCH).(4) SCH is a potentially serious condition that occurs when the posterior ciliary arteries or vortex veins burst, resulting in blood in the suprachoroidal region.(5)

Several medications are proved to be effective for prevention of nausea and vomiting like steroids, dopamine antagonists and serotonin antagonists. PONV is best prevented and treated with selective serotonin receptor antagonists. Although serotonin receptor antagonists are more successful than metoclopramide and dexamethasone in preventing and treating PONV, their usage is restricted due to their expensive cost and limited availability in resource-poor facilities.(6) In an attempt to decrease the incidence of PONV in the ambulatory setting, several anti-emetics have been studied.(7) For decades, metoclopramide has been a popular antiemetic due to its dose-dependent activity on central dopaminergic D2 receptors, central and peripheral 5-HT3 receptors, and peripheral 5-HT4 receptors. Despite inconsistent results, it is nevertheless commonly used in clinical practice to prevent nausea and vomiting after surgery.(8) Dexamethasone was utilized as a standalone medication during surgery for both pediatric and adult patients.(9) Recently, there has been a suggestion that dexamethasone, which has been shown to be more effective in preventing nausea and is thought to lower 5-HT levels in the central nervous system, could lower the incidence of PONV.(10)

The hypothesis is that dexamethasone will lower the incidence of PONV after cataract surgery when compared with metoclopramide.

Aim of the work:

The present study aims to test the efficacy of dexamethasone and metoclopramide in prevention of PONV in patients undergoing cataract surgery.

Primary outcome:

1- Incidence of PONV

Secondary outcomes:

  1. Number of patients took antiemetic drug in 24h
  2. RINVR score ( rhodes index of nausea, vomiting and retching
  3. Postoperative pain score
  4. number of doses of rescue antiemetic

Patients :

Study settings:

This study will be conducted in ophthalmology department, Alexandria university hospitals.

Study design:

Placebo-controlled, double blind, randomized, prospective study

Sample size calculation:

Study population:

All patients will be randomized 1:1 using a sealed envelope method. Patients will be divided into three equal groups:

Group P: patients will receive 0.9% normal saline

Group M: patients will receive 10 mg metoclopramide Group D: patients will receive 8 mg dexamethasone

Methods:

Preoperative evaluation and preparation:

During preoperative visit, evaluation of patients will be carried out through proper history taking, clinical examination and routine laboratory investigations including complete blood picture, coagulation profile, blood urea, serum creatinine, serum electrolytes and any other investigation needed.

Pre-anesthetic preparation and premedication:

  • Informed written consent, from all individual participants who will be included in this study will be taken during preoperative visit.
  • Patients should be trained during preoperative visit on a visual analogue scale (VAS), with 0 corresponding to no pain and 10 to the worst pain imaginable

On arrival to operative theatre, intravenous cannula will be inserted and standard monitoring will be established using multichannel monitor (Carescape Monitor B650, GE Healthcare Finland) to monitor the following in both groups:

  • Electrocardiogram (ECG) for heart rate and rhythm. (Beats/min).
  • Non-invasive measurement of arterial blood pressure. (Mean blood pressure in mmHg).
  • Pulse oxygen saturation. (SpO2%). Before sedation, patients will be randomly allocated to receive one of three drugs. Three 2-mL syringes containing either 8 mg dexamethasone,10 mg metoclopramide, or 0.9% saline per syringe will be prepared by an anesthetist who is not one of the observers. Syringes will be marked with a coded label. Patients in group P will receive 0.9% normal saline, group M will receive 10 mg metoclopramide and group D will receive 8 mg dexamethasone before sedation. All patients will be sedated with 0.025 mg /kg midazolam, 0.25 mg/kg ketamine and 0.05 mg/kg nalbuphine. Peribulbar block with 2 ml lidocaine 2% and 3 ml bupivacaine 0.5% will be given to all patients.

PONV is defined as proportion of patients experiencing any nausea VRS more than 1 or any vomiting or retching episode within the first 24 hours after surgery.

The rescue antiemetic will be ondansetron 4 mg IV, which will be given if nausea VRS more than 4 or any episode of vomiting or retching. Pain will be assessed using VAS. Nausea will be assessed using a verbal rating scale which is 11 point scale with 0 no nausea, 1-3 mild nausea, 4-6 moderate, 7-10 severe. The rescue analgesic will be intravenous ketorolac 30 mg if VAS >3. Nausea refers to the unpleasant sensation of wanting to vomit, while vomiting is the forceful ejection of gastric contents from the mouth.

Being tested
0.9% normal saline, Metoclopramide 10mg, Dexamethasone
Keywords
dexamethasone, cataract surgery
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.9% normal salineOther

    Also called group P

    patients in group P will receive 0.9% normal saline

  • Metoclopramide 10mgDrug

    Also called group M

    patients in group M will receive 10 mg metoclopramide

  • DexamethasoneDrug

    Also called group D

    patients in group D will receive 8 mg dexamethasone

Study groups in NCT07086118
Study groupRoleWhat they receive
group pPlacebo comparatorpatients will receive 0.9% normal saline
Receives: Other: 0.9% normal saline
group MActive comparatorpatients will receive 10 mg metoclopramide
Receives: Drug: Metoclopramide 10mg
group DActive comparatorpatients will receive 8 mg dexamethasone
Receives: Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of patients with nausea and vomiting

    number

    Measured: postoperative day 1

Secondary outcomes (4)
  1. vas score

    score

    Measured: postoperative day 1

  2. number of patients requiring antiemetic

    number

    Measured: postoperative day1

  3. incidence of dizziess, perineal burning and headache

    number

    Measured: postoperative day 1

  4. RINVR score

    symptom occurrence, symptom distress, symptom experience

    Measured: postoperative day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start1 May 2025
  3. Primary completion1 Oct 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07086118
Sponsor's protocol ID
0307296
Status last verified
Oct 2026
First submitted
18 Jul 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bilgin TE, Birbicer H, Ozer Z, Doruk N, Tok E, Oral U. A comparative study of the antiemetic efficacy of dexamethasone, ondansetron, and metoclopramide in patients undergoing gynecological surgery. Med Sci Monit. 2010 Jul;16(7):CR336-41.

    PubMed 20581776

Questions about this trial

What is this clinical trial studying?

A study testing 0.9% normal saline, Metoclopramide 10mg and Dexamethasone in people with Cataract and Dexamethasone, run by Alexandria University at 1 site in Egypt.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of patients with nausea and vomiting (time frame: postoperative day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07086118, which also lists 1 linked publication.

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 21 Oct 2026.

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