Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries: A Randomized Double-Blinded Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amount of intraoperative blood loss
研究概览
简要总结
Comparing of nasal packing DEX and IV DEX for controlling the intraoperative bleeding after turbinate surgery.
详细描述
Dexmedetomidine (DEX) is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes DEX primarily sedative and anxiolytic. The elimination half-life of DEX (t1/2b) is 2 h and the redistribution half-life (t1/2a) is 6 min, and this short half-life makes it an ideal drug for intravenous titration. Potentially desirable effects include decreased requirements for other anesthetics and analgesics.
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
- Double (Participant, Investigator)
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 to 65 years
- •Both sexes
- •American Society of Anesthesiologists (ASA) physical status classification I or II.
- •Undergo turbinate surgery
排除标准
- •Patients with a body mass index > 30 kg/m2 existing or recent significant disease.
- •Contraindications to the use of dexmedetomidine .
- •History or presence of a significant disease significant cardiovascular disease risk factors.
- •Significant coronary artery disease or any known genetic predisposition.
- •History of any kind of drug allergy,
- •Drug abuse.
- •Clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening.
- •Known systemic disease requiring the use of anticoagulants,
- •Patients with a history of previous turbinate surgery.
研究组 & 干预措施
Group NP (nasal packing Dexmedetomidine)
Patients will receive nasal packing Dexmedetomidine (1.5 μg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline.
干预措施: Nasal packing Dexmedetomidine (Drug)
Group IV (Intravenous Dexmedetomidine)
Patients will receive 0.5 μg/kg bolus over 10 min then 0.1- 0.4 μg/kg IV infusion Dexmedetomidine and nasal packing with saline.
干预措施: Intravenous Dexmedetomidine (Drug)
结局指标
主要结局
Amount of intraoperative blood loss
时间窗: Intraoperative up to 6hours
Measuring the volume of suctioned blood in graduated columns, which will contain an anticoagulant to prevent coagulation and clotting and weighing gauze sponges.
次要结局
- Pain score(24 hours postoperative)
- Quality of intraoperative surgical field(Intraoperative up to 6hours)
- Patient's general satisfaction(24 hours postoperative)
研究者
Gamal Hendawy Shams
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Kafr-El Sheikh University
Kafrelsheikh University