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临床试验/NCT07585201
NCT07585201已完成不适用

Impact of Dexmedetomidine Versus Nitroglycerin on Surgical Field Quality and Drug Cost in Functional Endoscopic Sinus Surgeries

Zagazig University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1

研究概览

简要总结

Sinus surgery is one of the most prevalent ear, nose, and throat (ENT) surgeries, which is mainly carried out nowadays through functional endoscopic sinus surgery (FESS) and leads to significant improvement in the clinical symptoms of patients with rhinosinusitis. It is necessary to maintain safe conditions for this surgery, and the major problem reported during FESS under general anesthesia (GA) is impaired visibility due to excessive amount of bleeding. This is particularly important for the successful surgery of the ethmoid and sphenoid sinuses because even minimum amount of bleeding might seriously impair the successful completion of the surgery, increase the operational risk, and increase surgery time which are major concerns for both anesthesiologist and ENT specialist.

Controlled hypotension is the commonly used technique to limit blood loss and improve visualization in the surgical field during FESS, various techniques have been adopted to achieve controlled hypotension, one of them is the use of pharmacological drugs in the form of volatile anesthetics, direct-acting vasodilators, autonomic ganglion-blockers, and α-adrenergic receptor blockers.

Alpha-2 (α-2) receptors are found in the peripheral and central nervous systems, platelets and many other organs including the liver, pancreas, kidney, and eye. Stimulation of the receptors in the brain and spinal cord inhibits neuronal firing causing hypotension, bradycardia, sedation, and analgesia. Alpha-2 (α-2) agonist drugs have sympatholytic, sedative, anesthetic, and analgesic sparing effects, as well as vasoconstrictive effects and thereby reduce intraoperative bleeding. Also, the use of α-2 agonists in the perioperative period has been associated with reduced anesthetic requirements, decreased heart rate and blood pressure.

Dexmedetomidine is a highly selective α-2 adrenergic receptor agonist (selectivity ratio for α2: α1 is 1600:1). The sympatholytic effect of dexmedetomidine made it attractive to be used as a hypotensive drug during surgery because of decreasing heart rate (HR) and cardiac output (CO) without decreasing stroke volume unless the plasma concentrates reaches above 5.1 μg/mL. The cardiovascular effects of dexmedetomidine begin with initial hypertension following the administration of a loading dose, due to the activation of α 2B receptors located on vascular smooth muscle, with subsequent hypotension and bradycardia due to centrally mediated decrease in sympathetic tone. Dexmedetomidine also has sedative, amnesic, anxiolytic, hypnotic, and analgesic effects with minimal changes in respiratory variables. Furthermore, it reduces postoperative nausea, vomiting, and shivering. It also reduces delirium in patients after cardiac surgery.

Nitroglycerin is a directly acting vasodilator drug frequently used to produce controlled hypotension because it is easily titratable and having very rapid onset as well as rapid offset of action. However, the disadvantages of nitroglycerin are reflex tachycardia and venous congestion which leads to increased blood loss.

Aim of the work was improving surgical field quality and drug cost in patients undergoing Functional Endoscopic Sinus Surgeries by comparing between dexmedetomidine and nitroglycerin.

详细描述

This study had been carried out in Anesthesia, Intensive Care and Pain management Department - Faculty of Medicine - Zagazig University Hospitals.

Sample size:

Assuming the average category scale was 73.33% vs 36.67% in group D vs group N, so the sample was 66 adult male and female undergoing FESS , 33 cases in each group (dexmedetomidine and nitroglycerin) using open EPI info with CI 95%, Power of test 80%.

Withdrawal criteria:

The patient has the right to withdraw from the study at any time without any negative consequences or harm on his/her medical treatment plan.

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, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Physical status: American Society of Anesthesiologists (ASA) I & II.
  • Body Mass Index (BMI): 18.5-30 kg/m
  • Type of operation: elective bilateral FESS.
  • Type of anesthesia: general anesthesia.

排除标准

  • Patients with known history of allergy to study drugs.
  • Anticipated difficult intubation.
  • Advanced hepatic, renal or cardiovascular diseases.
  • Central nervous system disorder, metabolic disease, and electrolyte imbalance.
  • Coagulopathies or taking drugs affecting coagulation.

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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