NCT07275450招募中不适用
Safety and Efficacy of Regional Anesthesia for Awake Tympanoplasty Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The time of discharge from Post Anesthesia Care Unit (PACU)
研究概览
简要总结
The aim of this study to evaluate efficacy of ultrasound guided regional anesthesia in performing awake tympanoplasty surgery versus traditional general anesthesia
详细描述
- To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty as regards:
- To assess the time of discharge from post anesthesia care unit
- To assess intraoperative hemodynamic parameters, quality of the surgical field and the block success rate (number of patients converted to general anesthesia).
- To assess postoperative parameters: Numerical Rating Scale , time to first request of analgesia, postoperative opioid consumption, patient and surgeon satisfaction in both groups.
- To assess the incidence of block-related complications (such as nerve injury, hematoma, inadequate block, or local anesthetic toxicity) or surgery related complications as nausea and vomiting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients acceptance
- •Age: 21-65 years old
- •Sex: both sex (males or females).
- •Physical status: American Society Anesthesiologist (ASA) І and II.
- •Patients will be scheduled for elective unilateral tympanoplasty.
排除标准
- •Contraindication of regional anesthesia: Coagulopathy or use of anticoagulant therapy -local infection at the site of injection- known allergy to local anesthetics (bupivacaine).
- •Neurological disorders affecting sensation in the head and neck.
- •Psychiatric illness, severe anxiety, or inability to cooperate during awake surgery.
- •History of previous neck or parotid surgery affecting nerve anatomy.
- •BMI > 35 (if it may interfere with ultrasound visualization or landmark identification).
- •Advanced cardiovascular, respiratory, hepatic and renal diseases
结局指标
主要结局
The time of discharge from Post Anesthesia Care Unit (PACU)
时间窗: 2 hours postoperative
The time from arrival to the Post Anesthesia Care Unit (PACU) to the time to discharge to the ward according to modified aldrete score
次要结局
- The incidence of block-related complications or surgery related complications(24 hours)
- Intraoperative mean arterial blood pressure(0 minute (basal) and every 5 minutes up to 2 hours)
- Surgeon satisfaction(duration of surgery (intraoperative))
- Intraoperative heart rate ( beat per minute)(before starting anesthesia 0 minute (basal )and every 5 minutes up to 2 hours)
- Pain intensity by using Numerical Rating Scale (NRS)(Post Anesthesia Care Unit (0 hour) , 2 hours, 4 hours, 8 hours, 12 hours and 24 hours)
- Block success rate(15-20 minutes (from finishing block till start surgery))
- Quality of surgical field(duration of surgery (intraoperative))
- Time to first request of analgesia(24 hours)
- Total postoperative analgesic consumption(24 hours)
- Patient satisfaction by Likert score(24 hours)
研究者
Dina Abdelhameed Elsadek Salem
Associate professor of anesthesia
Zagazig University
研究点 (1)
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