Effect of Dexmedetomidine on Tear Production in Angioplasty Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Sedation with Midazolam, Fentanyl, and Propofol.
- Who it may be relevant to
- Registry conditions: Tear Film Alteration. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Dexmedetomidine Sedation on Tear Film in Patients Undergoing Angioplasty Under Local Anesthesia
Overview
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.
Interventions
- Drug 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. - 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.
Primary outcome measures
- Change in Tear Production Measured by Schirmer I Test [Time frame: Baseline (30 minutes pre-procedure) to 30 minutes post-procedure]
Secondary outcome measures (4)
- Immediate Post-Procedure Tear Production (Schirmer I Test) [Time frame: 30-60 minutes after completion of the procedure]
- Patient-Reported Dry Eye Symptoms [Time frame: Baseline (pre-procedure), immediate post-procedure, and 12 hours post-procedure]
- Incidence of Ocular Adverse Events [Time frame: From start of procedure to 12 hours post-procedure]
- Total Dexmedetomidine Dose [Time frame: During the procedure]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Benha University Hospital — Banhā
Identifiers
NCT: NCT07326332 · RC.18.10.2025