Effect of Dexmedetomidine on Tear Production in Angioplasty Patients

Benha University

Status: Not yet enrolling

Conditions: Tear Film Alteration

Treatments: Drug: Dexmedetomidine; Drug: Sedation with Midazolam, Fentanyl, and Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT07326332

RC.18.10.2025

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Dexmedetomidine Sedation

Experimental group

Description:

Participants in this arm will be sedated with intravenous dexmedetomidine during angioplasty performed under local anesthesia. Dexmedetomidine will be administered as a loading dose (if clinically appropriate) followed by a continuous infusion titrated to achieve moderate sedation (RASS -2 to 0). Rescue sedation with small propofol boluses may be used if needed and will be recorded.

Treatment:

Drug: Dexmedetomidine

Standard Sedation

Active Comparator group

Description:

Participants in this arm will receive standard sedation according to routine clinical practice during angioplasty under local anesthesia. Sedation may include intermittent intravenous boluses of midazolam with or without opioid analgesics (e.g., fentanyl) and/or small propofol boluses, titrated to achieve moderate sedation (RASS -2 to 0).

Treatment:

Drug: Sedation with Midazolam, Fentanyl, and Propofol