Effect of Dexmedetomidine on Tear Production in Angioplasty Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBenha University

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dexmedetomidine
  • Sedation with Midazolam, Fentanyl, and Propofol

Treatment groups

52 Participants
are divided into 2 treatment groups

Sponsors and collaborators