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临床试验/NCT05595083
NCT05595083招募中不适用

Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of the Operative Field in Functional Endoscopic Sinus Surgery: A Randomized Triple-Blind Trial

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
1
主要终点
Formmer's scores of surgical field quality

研究概览

简要总结

The aim of this study is to compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving the quality of the operative field in Functional endoscopic sinus surgery (FESS).

详细描述

Functional endoscopic sinus surgery (FESS) is a well-established therapeutic option for intractable Cytokine release syndrome (CRS) and other indications. Functional endoscopic sinus surgery (FESS) is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, the risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid [CSF] leakage, and the duration of surgery increase . Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications .

Increased bleeding sometimes causes surgeries to end before the due time. Improvement of intraoperative visibility while reducing bleeding is an important task for anesthesiologists during Functional endoscopic sinus surgery (FESS).

For this purpose, several pharmaceuticals have been used successfully to produce controlled hypotension during general anesthesia, for example inhalational anesthetics, direct vasodilators (sodium nitroprusside and nitroglycerin), beta adrenergic antagonists (propranolol and esmolol), alpha adrenergic agonists (clonidine and dexmedetomidine), calcium channel blockers, prostaglandin E1 (alprostadil) and adenosine and l-receptors agonists (remifentanil) .

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. Potentially desirable effects include decreased requirements for other anesthetics and analgesics. The most common adverse effects associated with Dexmedetomidine include hypotension, bradycardia, and even hypertension.

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 ug/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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years of age
  • Both genders
  • American Society of Anesthesiologists (ASA) physical status classification I or II
  • Undergoing Functional Endoscopic Sinus Surgery.

排除标准

  • Patients with a body mass index > 30 kg/m^2
  • 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 group

Experimental

patients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline

干预措施: intranasal dexmedetomidine group (Drug)

intravenous dexmedetomidine group

Experimental

patients will receive 0.1- 0.4 ug/kg intravenous infusion dexmedetomidine + intranasal saline.

干预措施: intravouns dexmedetomidine group (Drug)

结局指标

主要结局

Formmer's scores of surgical field quality

时间窗: Intraoperatively

Formmer's scores (a 6-point scale) of surgical field quality will be used to record the amount of bleeding (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)

次要结局

  • Adverse reactions(24 hour postoperatively)
  • Pain level(24 hour postoperatively)
  • Hemodynamics effects(at baseline and every 5 min till the end of procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Fouad Algyar

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Kafrelsheikh University

研究点 (1)

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