Effect of Dexmedetomidine on Tear Production in Angioplasty Patients

Официальное название

Effect of Dexmedetomidine Sedation on Tear Film in Patients Undergoing Angioplasty Under Local Anesthesia

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Change in Tear Production Measured by Schirmer I Test [Срок оценки: Baseline (30 minutes pre-procedure) to 30 minutes post-procedure]

Вторичные конечные точки (4)

• Immediate Post-Procedure Tear Production (Schirmer I Test) [Срок оценки: 30-60 minutes after completion of the procedure]
• Patient-Reported Dry Eye Symptoms [Срок оценки: Baseline (pre-procedure), immediate post-procedure, and 12 hours post-procedure]
• Incidence of Ocular Adverse Events [Срок оценки: From start of procedure to 12 hours post-procedure]
• Total Dexmedetomidine Dose [Срок оценки: During the procedure]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Benha University Hospital — Banhā

Идентификаторы

NCT: NCT07326332 · RC.18.10.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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