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临床试验/NCT06620991
NCT06620991尚未招募不适用

Pre-operative Phentolamine Vs Intraoperative Esmolol Efficacy for Hypotensive Anesthesia in Functional Endoscopic Sinus Surgery

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月10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
尚未招募
入组人数
60
试验地点
1
主要终点
Mean arterial pressure

研究概览

简要总结

The aim of this study is to evaluate the efficacy of intra-operative phentolamine vs intraoperative esmolol for hypotensive anesthesia in functional endoscopic sinus surgery.

详细描述

Functional endoscopic sinus surgery (FESS) is becoming a widely performed operation. Its introduction associated with enhanced illumination and visualization has dramatically improved surgical dissection. However major complications have been reported for FESS under general anesthesia resulting from impaired visibility due to excessive bleeding.

Esmolol is a selective β1-adrenoreceptor antagonist involved in the control of heart rate (HR), contractility, and atrioventricular conduction. Currently, the use of β-blockade for hemodynamic stability and cardiac protection is well accepted among anesthesia providers, but recently, researchers have begun to explore the perioperative use of esmolol as an anesthetic adjunct. Esmolol was found to produce desired hypotension without tachycardia and improved surgical condition by reducing operative field bleeding.

Phentolamine is well known selective α1-blocker which is used to treat hypertensive emergency by producing profound vasodilatation. The reduced blood pressure will induce response in the arterial baroreceptors leading to release of adrenal catecholamine, eventually inducing reflex tachycardia. The reflex tachycardia is less profound in the selective α1-blockers such as phentolamine. Phentolamine is a short acting drug with a context sensitive half-life of 15 minutes which makes it ideal for rapid control of blood pressure.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 21 to 50 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I-II.

排除标准

  • Patients with a medical condition that contraindicated hypotensive anesthesia, such as peripheral vascular disease, cerebrovascular stroke, carotid artery stenosis, previous myocardial infarction, ischemic heart disease, congestive heart failure, limb ischemia, uncontrolled hypertension and raised intracranial tension
  • Renal disease, liver dysfunction, pregnancy.
  • Patients on hypnotic or narcotic analgesic.
  • History of alcohol or drug abuse.
  • History of allergic reaction to any drug used in this study.
  • Bleeding diathesis.
  • Previous nasal surgery.
  • Patients on Non-steroidal anti-inflammatory drugs (NSAIDs).
  • Patients with peripheral vascular disease.

研究组 & 干预措施

Phentolamine

Experimental

A loading dose of 1-5 mg IV bolus over 1 minute is given followed by an IV infusion of a rate of 0.1-2 mg/min according to patient desired target mean arterial pressure (MAP) 50-60 mmHg over a volume of 10ml.

干预措施: Phentolamine (Drug)

Esmolol

Experimental

A loading dose of 1 mg/kg IV infused over 1 minute is given followed by an IV infusion of 0.15-0.3 mg/kg/min according to patient desired target mean arterial pressure (MAP) 50-60 mmHg over total volume of 10ml.

干预措施: Esmolol (Drug)

结局指标

主要结局

Mean arterial pressure

时间窗: Until the end of surgery.

Mean arterial pressure will be recorded at pre-induction, after the loading dose of the hypotensive agent, after injection of local vasoconstrictor and then every 15 minutes until the end of surgery.

次要结局

  • Heart rate(Until the end of surgery)
  • Adverse events(24 hours postoperative)

研究者

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

Eslam Elsamahi

Assistant lecturer of intensive care unit and anesthesia, Faculty of Medicine, Ain Shams University, Egypt.

Ain Shams University

研究点 (1)

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