Effect of Dexmedetomidine on Tear Production in Angioplasty Patients
ConditionTear Film Alteration
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugDexmedetomidine 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.
Sedation with Midazolam, Fentanyl, and Propofol
DrugStandard 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.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine SedationExperimental treatment 1 intervention
Group B: Standard SedationActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (30 minutes pre-procedure) to 30 minutes post-procedureSecondary outcomes
1
Immediate Post-Procedure Tear Production (Schirmer I Test)
Tear production measured using the Schirmer I test (mm) immediately after the procedure, once the patient is responsive (Aldrete score ≥9), and compared between study groups.
Time frame
30-60 minutes after completion of the procedure2
Patient-Reported Dry Eye Symptoms
Dry eye symptoms assessed using a visual analog scale (VAS) ranging from 0 to 10, where 0 = no dry eye symptoms and 10 = worst imaginable dry eye symptoms.
Time frame
Baseline (pre-procedure), immediate post-procedure, and 12 hours post-procedure3
Incidence of Ocular Adverse Events
Occurrence of ocular adverse events, including corneal abrasion, corneal epithelial defects, conjunctival hyperemia, blurred vision, or severe dry eye requiring ophthalmologic consultation.
Time frame
From start of procedure to 12 hours post-procedure4
Total Dexmedetomidine Dose
Total cumulative dose of dexmedetomidine administered during the procedure, expressed in micrograms (µg).
Time frame
During the procedureSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: