Intranasal Premedication With Dexmedetomidine Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia During Functional Endoscopic Sinus Surgery in Adults: A Randomized Triple-Blind 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
- Improving quality of the operative field.
研究概览
简要总结
Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus surgery.
Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 21 years of age.
- •Both genders.
- •American Society of Anesthesiologists (ASA) physical status classification I - III who underwent functional endoscopic sinus 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.
- •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.
- •Any nasal disorders that may hinder nasal administration of the drugs as repeated nasal bleeding or nasal tumors.
- •Patients with a history of previous functional endoscopic sinus surgery.
研究组 & 干预措施
Intranasal dexmedetomidine group
30 patients will receive 1µg/kg dexmedetomidine diluted in 10ml 0.9% saline intranasally preoperative administered to each naris as drops 45 -60 min before the operation +infusion saline.
干预措施: Intranasal dexmedetomidine (Drug)
Intravenous dexmedetomidine group
30 patients will receive a dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia + 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: during surgery (intraoperatively) 2 hours
Quality of intraoperative surgical field during functional endoscopic sinus surgery will be evaluated by the surgeons by rating the amount of bleeding according to a 6-point scale by Formmer's scores of surgical field quality (0= no bleeding; 1= bleeding, so mild it was not even a surgical nuisance; 2= moderate bleeding, a nuisance but without interference; 3= moderate bleeding that moderately compromised surgical; 4= bleeding, heavy but controllable, that significantly interfered; 5= massive uncontrollable bleeding.
Amount of atropine consumption
时间窗: First 24 hours postoperatively
The total amount of atropine consumed will be recorded
次要结局
- Hemodynamics(Heart rate (bpm))(2 hours)
- Hemodynamics(Mean arterial blood pressure mm Hg))(2 hours)
- Pain score(First 24 hours postoperatively)
- hemostatic stuffing(24 hours postoperatively)
- Adverse events(24 postoperatively)
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University