Effect of Bilateral Trans-nasal Sphenopalatine Ganglion Block on Emergence Agitation Following Functional Endoscopic Sinus Surgery: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This randomized double-blind controlled trial aims to evaluate whether bilateral trans-nasal sphenopalatine ganglion block (SPGB) using bupivacaine reduces the incidence of emergence agitation following Functional Endoscopic Sinus Surgery (FESS) compared with placebo. Secondary objectives include evaluation of postoperative pain, postoperative opioid consumption, hemodynamic parameters, postoperative nausea and vomiting, and adverse events.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study solution was prepared in identical syringes by a scrub nurse who was not involved in patient management, outcome assessment, data collection, or statistical analysis. Participants, the surgeon performing the block and surgery, the attending anesthesiologist, outcome assessors, investigators, and the statistician remained blinded to treatment allocation throughout the study.
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
- •Age 18-65 years.
- •ASA physical status I-II.
- •Scheduled for elective FESS under general anesthesia.
- •Ability to provide informed consent.
排除标准
- •ASA physical status III or higher.
- •Known allergy or contraindication to local anesthetics.
- •Coagulopathy or anticoagulant therapy.
- •Psychiatric illness or cognitive impairment affecting agitation assessment.
- •Chronic opioid use or substance abuse.
- •Pregnancy or lactation.
- •Revision nasal surgery or anatomical abnormalities preventing SPGB.
- •Intraoperative complications requiring deviation from the study protocol.