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.
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.
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:
- Number of patients took antiemetic drug in 24h
- RINVR score ( rhodes index of nausea, vomiting and retching
- Postoperative pain score
- 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.
- Conditions
- Cataract, Dexamethasone
- 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 group | Role | What they receive |
|---|---|---|
| group p | Placebo comparator | patients will receive 0.9% normal saline Receives: Other: 0.9% normal saline |
| group M | Active comparator | patients will receive 10 mg metoclopramide Receives: Drug: Metoclopramide 10mg |
| group D | Active comparator | patients 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.
number of patients with nausea and vomiting
number
Measured: postoperative day 1
Secondary outcomes (4)
vas score
score
Measured: postoperative day 1
number of patients requiring antiemetic
number
Measured: postoperative day1
incidence of dizziess, perineal burning and headache
number
Measured: postoperative day 1
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.
- First posted25 Jul 2025
- Study start1 May 2025
- Primary completion1 Oct 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- 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)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah mohamed, Alexandria University
- Investigators
- sarah m elgamal, MD, Principal investigator, Alexandria University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexamethasone Versus Metoclopramide for Prophylaxis of Nausea and Vomiting After Cataract Surgery: A Double-blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07086118
- Acronym / sponsor ID
- 0307296
- Conditions
- Cataract, Dexamethasone
- Keywords
- dexamethasone, cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 25 Jul 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.
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.
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:
- Number of patients took antiemetic drug in 24h
- RINVR score ( rhodes index of nausea, vomiting and retching
- Postoperative pain score
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group p | Placebo comparator | Other: 0.9% normal salinepatients will receive 0.9% normal saline |
| group M | Active comparator | Drug: Metoclopramide 10mgpatients will receive 10 mg metoclopramide |
| group D | Active comparator | Drug: Dexamethasonepatients will receive 8 mg dexamethasone |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 40-80 years, both sexes.
- ASA physical status class I to III.
- Apfel score 0-2
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 0.9% normal salineAlso: group Ppatients in group P will receive 0.9% normal saline | Other | group p |
| Metoclopramide 10mgAlso: group Mpatients in group M will receive 10 mg metoclopramide | Drug | group M |
| DexamethasoneAlso: group Dpatients in group D will receive 8 mg dexamethasone | Drug | group D |
Primary outcome
number of patients with nausea and vomiting
Time frame: postoperative day 1
number
4 secondary outcomes
vas score
Time frame: postoperative day 1
number of patients requiring antiemetic
Time frame: postoperative day1
incidence of dizziess, perineal burning and headache
Time frame: postoperative day 1
RINVR score
Time frame: postoperative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 20581776Bilgin 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
sarah m elgamal, MD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
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.