Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of the Operative Field in Functional Endoscopic Sinus Surgery: A Randomized Triple-Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Improving quality of the operative field
研究概览
简要总结
compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery
详细描述
Functional endoscopic sinus surgery is a well-established therapeutic option for intractable CRS and other indications. Functional endoscopic sinus surgery is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid leakage and the duration of surgery increase. Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications.
Dexmedetomidine is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes dexmedetomidine primarily sedative and anxiolytic.The elimination half-life of dexmedetomidine (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.
Intranasal Dexmedetomidine is convenient, effective, and noninvasive and also has useful analgesic and sedative effects in surgical procedures. Cheung's research has shown that intranasal Dexmedetomidine 1 and 1.5 micro/kg in surgical procedures produced significant sedation and less postoperative pain. Several previous research were determined the effect of intranasal dexmedetomidine in several clinical evaluations
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients underwent Functional Endoscopic Sinus Surgery
- •American Society of Anesthesiologists (ASA) physical status classification I or II
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
- •psychological or other emotional problems
- •special diet or lifestyle
- •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 Functional Endoscopic Sinus Surgery
研究组 & 干预措施
intranasal dexmedetomidine
Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline
干预措施: intranasal dexmedetomidine (Drug)
intravenous dexmedetomidine
patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.
干预措施: intravenous dexmedetomidine (Drug)
结局指标
主要结局
Improving quality of the operative field
时间窗: 24 hours postoperative
Patients' satisfaction will be measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.
次要结局
- Heart rate will be evaluated(every 5 min till the end of procedure)
- Mean arterial blood pressure will be evaluated.(every 5 min till the end of procedure)
- Adverse reactions of hemostatic stuffing after FESS will be evaluated.(24 hour postoperatively)
- Pain score will be evaluated.(24 hour postoperatively)
研究者
Mohamed Fouad Algyar
Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine
Kafrelsheikh University