Effect of Dexmedetomidine on Tear Production in Angioplasty Patients

Starting soon · Not applicable

Conditions studied: Tear Film Alteration

In brief

During medical procedures performed under local anesthesia with sedation, such as angioplasty, the eyes may become dry because normal blinking and tear production can be reduced. Dexmedetomidine is a commonly used sedative that provides comfort and pain relief while allowing patients to breathe on their own. However, there is limited information about how dexmedetomidine affects tear production and eye comfort after procedures. This study aims to evaluate whether sedation with dexmedetomidine affects tear production compared with standard sedative medications used during angioplasty. Adult patients undergoing angioplasty under local anesthesia will be randomly assigned to receive either dexmedetomidine sedation or standard sedation. Tear production will be measured using the Schirmer test before the procedure, shortly after the procedure, and 12 hours later. Patients will also be asked about eye dryness or discomfort, and any eye-related or sedation-related side effects will be recorded. The results of this study may help improve eye safety and comfort in patients receiving sedation during angioplasty and guide the selection of sedative medications in clinical practice.

Key facts

Study ID

NCT07326332

Run by

Benha University

People needed

52

Starts

2026-01-01

Expected to finish

2026-06-20

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled for elective angioplasty (coronary PCI or peripheral angioplasty) under local anesthesia with planned procedural sedation.
• Able to give informed consent and complete ocular symptom assessments.
• Baseline Schirmer I ≥1 mm (to exclude complete anatomic lacrimal failure; you may alter this cutoff).

You may not qualify if…

• Pre-existing moderate/severe dry eye disease or Sjögren's syndrome (history or OSDI >33).
• Ocular surgery within prior 3 months or active ocular infection.
• Contact lens use within 24 hours before baseline.
• Chronic systemic medications known to substantially alter lacrimation (recent anticholinergics, high-dose tricyclics) unless stable and documented.
• Known allergy to dexmedetomidine, midazolam, fentanyl, or propofol.
• Significant bradycardia (HR <50) or high-degree AV block without pacemaker.
• Pregnancy or breastfeeding.
• Any condition making study participation or follow-up impossible.

Where it is running

• Benha University Hospital — Banhā, Qalyubia Governorate, Egypt

Full record on ClinicalTrials.gov

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