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临床试验/NCT04996576
NCT04996576已完成不适用

Infrazygomatic Versus Intranasal Injection Approaches of Sphinopalatine Ganglion Blockade Effect on Surgical Field in Functional Endoscopic Sinus Surgeries

Ain Shams University4 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年9月15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
35
试验地点
4
主要终点
surgical field quality

研究概览

简要总结

This study aimed to show the effect of sphinopalatine ganglion blockade on surgical field, hemodynamics and postoperative pain in FEES operation.

详细描述

Functional endoscopic sinus surgery (FESS) is a minimally invasive, effective surgical technique that is commonly used to treat chronic rhino sinusitis and nasal polyposis.

Intra-operative bleeding obscures the surgical view and increases the likelihood of iatrogenic complications. There are many factors that can affect the amount of bleeding experienced during surgery including both patient and surgical factors. These include severe forms of chronic sinusitis with nasal polyposis which is associated with increased vascularity, use of anticoagulant therapy, bleeding disorders, active infection, vascular tumor on the surgical site and revision surgery may affect bleeding on surgical site.

Sphenopalatine ganglion (SPG) is the main sensory innervation to the nasal mucosa.

The Sphenopalatine ganglion block (SPGB) is one of the regional anesthetic techniques that were used effectively before removal of nasal packing and in patients undergoing endoscopic sinus surgery under general anaesthesia to control bleeding or for postoperative analgesia

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Patients of ASA physical status I-II.

排除标准

  • Patients of ASA physical status III or above.
  • Patients with clinically significant cardiovascular, pulmonary or hepatic disease.
  • Patients with bleeding diathesis or on anticoagulant therapy.
  • Age less than 21 years.
  • Mentally disabled patients.

结局指标

主要结局

surgical field quality

时间窗: during the surgery

bloodless clear surgical field will be assessed for each side by surgeon using five categories categories. 1. = uncontrolled bleeding. 2. = severe bleeding, surgical conditions distorted immediately afterwards suctioning. 3. = moderate bleeding, frequent suctioning required, visibility of the surgical field is moderate. 4. = slight bleeding, occasional suctioning required, visibility of the surgical field is good. 5. = no bleeding almost bloodless surgical field.

次要结局

  • Postoperative pain(immediately after the surgery and 12 , 24 hours after the surgery)
  • postoperative infection(after the surgery( up to 24 hours))
  • postoperative epistaxis(after the surgery( up to 24 hours))
  • blood pressure(during the surgery and after the surgery( up to 24 hours))
  • heart rate(during the surgery and after the surgery( up to 24 hours))

研究者

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

Wael Elswefi

principal investigator

Ain Shams University

研究点 (4)

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