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Evaluation of the Effect of Fast-Dissolving Sublingual Films of ondansetron on the Control of Nausea and Vomiting after Eye Surgery

Formulation of Fast-Dissolving Sublingual Films of ondansetron Succinate by Electrospinning method and physicochemical and clinical evaluation in eye surgery patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180120038450N2
Enrollment
120
Registered
2019-08-17
Start date
2019-08-22
Completion date
Unknown
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients candidate for eye surgery.

Interventions

Intervention 1: Intervention group: In this study, we use ondansetron, which is made as a sublingual film with polyvinyl alcohol and beta-cyclodextrin polymers. Films containing 4 mg ondansetron are g

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Signature of written consent for participation in the study Age between 20 and 50 years From the point of view of classification of physical condition the American Society of Anesthesiologists was in the 1st and 2nd position

Exclusion criteria

Exclusion criteria: Pregnancy, breastfeeding Taking drugs with anti-nausea effect in 24 hours before surgery History of motion sickness The history of systemic diseases: heart, kidney, liver, lung, psychosis, diabetes Nausea and vomiting within 24 hours before of eye surgery Use of steroids 24 hours before surgery

Design outcomes

Primary

MeasureTime frame
The amount of nausea and vomiting. Timepoint: Baseline (immediately after surgery and before drug administration) and 1, 2, 4, 6 hours after drug administration. Method of measurement: Questionnaire with visual analogue scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahla Mirzaeei

Kermanshah University of Medical Sciences

shahlamirzaeei@gmail.com+98 83 3824 0526

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026