Effect of Dexmedetomidine on Tear Production in Angioplasty Patients

NCT ID: NCT07326332

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-06-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine Sedation

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

Standard Sedation

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).

Group Type: ACTIVE_COMPARATOR

Sedation with Midazolam, Fentanyl, and Propofol

Intervention Type: 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.

Interventions

Dexmedetomidine

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.

Intervention Type: DRUG

Sedation with Midazolam, Fentanyl, and Propofol

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Samar Rafik Mohamed Amin

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University Hospital

Banhā, Qalyubia Governorate, Egypt

Countries

Egypt

Central Contacts

Samar R Amin, M.D.

Role: CONTACT

samar.rafik@gmail.com

+201287793991

Facility Contacts

Samar Amin

Role: primary

samar.rafik@gmail.com

+201287793991

Other Identifiers

RC.18.10.2025

Identifier Type: -

Identifier Source: org_study_id