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临床试验/NCT05738135
NCT05738135已完成不适用

Effect of Intravenous Aminophylline on Hemodynamics and Recovery of Patients Undergoing Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia: A Randomized Controlled Study

Tanta University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年2月25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
已完成
入组人数
52
试验地点
1
主要终点
Time to extubation

研究概览

简要总结

This study will be conducted to evaluate the effect of intravenous aminophylline on hemodynamics and recovery of patients receiving dexmedetomidine infusion during functional endoscopic sinus surgery.

详细描述

Aminophylline is a nonselective adenosine receptor antagonist used for the treatment of asthma and chronic obstructive pulmonary disease. It has been used to antagonize the effects of anaesthetic and analgesic agents

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 to 50 years, have American society of anesthesiology (ASA) physical status I - II and scheduled for elective FESS under general anesthesia and receiving dexmedetomidine infusion for controlled hypotension during surgery.

排除标准

  • Patients with central nervous system diseases, cardiovascular diseases, hypertension, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
  • Pregnancy or lactation.
  • Patients with a history of allergy to aminophylline.
  • Patients with recurrent sinus surgery, hypertension.

研究组 & 干预措施

Aminophylline group

Experimental

Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.

干预措施: Aminophylline group (Drug)

Control group

Placebo Comparator

Patients will receive 50 ml normal saline over 30 minutes.

干预措施: normal saline (Drug)

结局指标

主要结局

Time to extubation

时间窗: Two hours after discontinuation of anesthetics

Extubation time, defined as the interval between the discontinuation of anesthetics to safe tracheal extubation.

次要结局

  • Intraoperative mean arterial blood pressure(Intraoperative period)
  • Time to discharge from post anesthesia care unit(Two hours after tracheal extubation.)
  • Intraoperative heart rate(Intraoperative period)
  • Postoperative sedation score(60 minutes after tracheal extubation)

研究者

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

Osama Rehab

Lecturer of Anesthesiology, Intensive Care and Pain Medicine

Tanta University

研究点 (1)

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