NCT07086118

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 18, 2025

Last Update Submit

July 18, 2025

Conditions

CataractDexamethasone

Keywords

dexamethasonecataract surgery

Outcome Measures

Primary Outcomes (1)

  • number of patients with nausea and vomiting

    number

    postoperative day 1

Secondary Outcomes (3)

  • vas score

    postoperative day 1

  • number of patients requiring antiemetic

    postoperative day1

  • incidence of dizziess, pruritis and headache

    postoperative day 1

Study Arms (3)

group p

PLACEBO COMPARATOR

patients will receive 0.9% normal saline

Other: 0.9% normal saline

group M

ACTIVE COMPARATOR

patients will receive 10 mg metoclopramide

Drug: Metoclopramide 10mg

group D

ACTIVE COMPARATOR

patients will receive 8 mg dexamethasone

Drug: Dexamethasone

Interventions

0.9% normal salineOTHER

patients in group P will receive 0.9% normal saline

Also known as: group P
group p
Metoclopramide 10mgDRUG

patients in group M will receive 10 mg metoclopramide

Also known as: group M
group M
DexamethasoneDRUG

patients in group D will receive 8 mg dexamethasone

Also known as: group D
group D

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 20581776BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Saline SolutionMetoclopramideDexamethasone

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsBenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenolsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • sarah m elgamal, MD

    Alexandria University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sarah m elgamal, MD

CONTACT

01005496440sarahelgamal1990@yahoo.com

moutaz ghandour, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

July 18, 2025

First Posted

July 25, 2025

Study Start

May 1, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)