Effect of Dexmedetomidine on Tear Production in Angioplasty Patients

NCT07326332 | Not Yet Recruiting

• 1 other identifier: RC.18.10.2025
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tear Film Alteration

Outcome Measures

Primary Outcomes (1)

• Change in Tear Production Measured by Schirmer I Test

  Change in tear production measured by the Schirmer I test (without topical anesthesia), calculated as the difference in millimeters (mm) between baseline (pre-procedure, awake) and immediate post-procedure measurement once the patient is responsive (Aldrete score ≥9). Measurements will be performed in a standardized manner by a trained, blinded assessor.

  Baseline (30 minutes pre-procedure) to 30 minutes post-procedure

Secondary Outcomes (4)

• Immediate Post-Procedure Tear Production (Schirmer I Test)

  30-60 minutes after completion of the procedure

• Patient-Reported Dry Eye Symptoms

  Baseline (pre-procedure), immediate post-procedure, and 12 hours post-procedure

• Incidence of Ocular Adverse Events

  From start of procedure to 12 hours post-procedure

• Total Dexmedetomidine Dose

  During the procedure

Study Arms (2)

Dexmedetomidine Sedation

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Standard Sedation

ACTIVE COMPARATOR

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).

Drug: Sedation with Midazolam, Fentanyl, and Propofol

Interventions

Dexmedetomidine DRUG

Dexmedetomidine will be administered intravenously for procedural sedation during angioplasty under local anesthesia. A loading dose of 0.4-0.6 µg/kg may be given over 10 minutes at the discretion of the anesthesiologist, followed by a continuous infusion of 0.2-0.7 µg/kg/hour titrated to achieve moderate sedation (RASS -2 to 0). Rescue sedation with small propofol boluses may be used if required and will be documented.

Dexmedetomidine Sedation

Sedation with Midazolam, Fentanyl, and Propofol DRUG

Standard sedation will be provided 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). All administered drugs and cumulative doses will be recorded.

Standard Sedation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Midazolam; Fentanyl; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Samar R Amin, M.D.

CONTACT

+201287793991; samar.rafik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

EG (1)