Benha University Hospital
Banhā, Qalyubia Governorate, 13511, Egypt
Not Yet Recruiting
NCT Number: NCT07326332
Effect of Dexmedetomidine on Tear Production in Angioplasty Patients
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
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.
Primary outcomes
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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
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Immediate Post-Procedure Tear Production (Schirmer I Test)
Time frame: 30-60 minutes after completion of the procedure
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.
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Patient-Reported Dry Eye Symptoms
Time frame: Baseline (pre-procedure), immediate post-procedure, and 12 hours post-procedure
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.
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Incidence of Ocular Adverse Events
Time frame: From start of procedure to 12 hours post-procedure
Occurrence of ocular adverse events, including corneal abrasion, corneal epithelial defects, conjunctival hyperemia, blurred vision, or severe dry eye requiring ophthalmologic consultation.
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Total Dexmedetomidine Dose
Time frame: During the procedure
Total cumulative dose of dexmedetomidine administered during the procedure, expressed in micrograms (µg).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Benha University
Other
Registry information
Official study title
Effect of Dexmedetomidine Sedation on Tear Film in Patients Undergoing Angioplasty Under Local Anesthesia
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 8, 2026
- Registry last updated
- Jan 8, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.