跳至主要内容
临床试验/NCT05301634
NCT05301634已完成3 期

Comparison Between Hemodynamic Effect of Bilateral Infraorbital Block Versus Intranasal Application of Bupivacaine in Patients Undergoing Transsphenoidal Pituitary Adenoma Resection.A Comparative Randomized Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月2日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Mean arterial blood pressure

研究概览

简要总结

The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I, II or III
  • patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia

排除标准

  • Patient's refusal
  • Allergy to local anesthetics.
  • Preoperative cerebrospinal fluid leak.
  • Preoperative cardiac arrythmias.
  • Seizure disorders.
  • Patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features.

结局指标

主要结局

Mean arterial blood pressure

时间窗: at the time of mucosal dissection

次要结局

  • Intraoperative need for nitroglycerine(the entire duration of surgery)
  • Postoperative need of pethidine(24 hours postoprative)
  • Intraoperative need for magnesium sulphate(the entire duration of surgery)
  • Intraoperative need for fentanyl(the entire duration of surgery)
  • Postoperative pain assessed by Numeric pain score(24 hours postoprative)

研究者

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

AbdElKhalik Mahmoud Shaban

Lecturer of anaesthesia

Cairo University

研究点 (1)

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