Effect of Dexmedetomidine Sedation on Tear Film in Patients Undergoing Angioplasty Under Local Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in Tear Production Measured by Schirmer I Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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).
干预措施: Sedation with Midazolam, Fentanyl, and Propofol (Drug)
结局指标
主要结局
Change in Tear Production Measured by Schirmer I Test
时间窗: 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.
次要结局
- 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)
研究者
Samar Rafik Mohamed Amin
Assistant professor
Benha University