Effect of Dexmedetomidine Sedation on Tear Film in Patients Undergoing Angioplasty Under Local Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Benha University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change in Tear Production Measured by Schirmer I Test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Dexmedetomidine (Drug)
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).
Intervention: Sedation with Midazolam, Fentanyl, and Propofol (Drug)
Outcomes
Primary Outcomes
Change in Tear Production Measured by Schirmer I Test
Time Frame: Baseline (30 minutes pre-procedure) to 30 minutes post-procedure
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.
Secondary Outcomes
- 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)
Investigators
Samar Rafik Mohamed Amin
Assistant professor
Benha University