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临床试验/NCT06686511
NCT06686511已完成不适用

The Effect of Preoperative Counseling on Emergence Agitation in Patients Candidate for Nasal Surgeries : a Prospective Randomized Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2024年11月25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
256
试验地点
1
主要终点
The incidence of emergence agitation using AONO s scale(percentage of patients having score of 3 or 4)

研究概览

简要总结

Emergence agitation is a post anesthetic phenomenon that develops in the early phase of general anesthesia recovery,The aim of our study to investigate the effect of preoperative educational counselling of the patient undergoing nasal surgery on emergence agitation .

详细描述

While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children. Especially, our clinical impression is that nasal surgical patients admitted to the postbanesthesia care unit (PACU) have suffered emergence agitation more frequently than other surgical patients, possibly due to a sense of suffocation during emergence from anesthesia.

preoperative counselling and repeated verbal stimulation of orientation may serve as a simple and easily applicable strategy to reduce emergence agitation after general anaesthesia .

There have been studies looking into the effect of pre-operative counselling on individual aspects internationally like anxiety, BMI, serum cholesterol , length of stay , pain .( Six trials were identified and have produced conflicting findings. Some trials have demonstrated the effects of preoperative education on improving physical and psychosocial recovery of cardiac patients, while others found no evidence that patients' anxiety is reduced or of any effect on pain or hospital stay) .

To our knowledge there was no study investigating the impact of preoperative counselling on postoperative agitation following nasal surgeries, The aim of our study to investigate the effect of preoperative educational counselling of the patient undergoing nasal surgery on emergence agitation .

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders.
  • Patients undergoing nasal surgery
  • American Society of Anesthesiologist (ASA) I or II physical status.
  • Between 18 and 65 years of age.

排除标准

  • ● Patients with communication difficulties.
  • ASA Ⅲ and Ⅳ patients.
  • Mentally retarded patients.
  • In-ability to postpone anti-coagulation medications.
  • Central or peripheral neurological disease.
  • Drug or alcohol abuse.
  • Localized infection at nose.
  • Bleeding disorder (platelets count less than 100,000 or INR more than 1.4)

研究组 & 干预措施

- Group A

Will ask them to close their nose completely by their hands and take their breath only from the mouth for 2 to 3 minutes before induction of GA.

: immediately after extubation we will tell them many times at their ear that the operation has been finished and ask them to take their breath from the mouth as they counselled and trained at preoperative period

● Group B

Will start the induction of anesthesia without any preoperative counselling of nasal closure .

this group will undergo extubation and should be instructed to use their nose for breathing without Without preoperative counselling

结局指标

主要结局

The incidence of emergence agitation using AONO s scale(percentage of patients having score of 3 or 4)

时间窗: scale immediately after extubation and then every 5 minutes for 20 minutes

● AONO s four point agitation scale The scale is decribed as 1 = calm; 2 = not calm but could be easily calmed; 3 = not easily calmed, moderately agitated or restless; and 4 = combative, excited, or disoriented.

次要结局

  • heart rate in beats per minute(immediately after extubation and then every 5 minutes for 20 minutes)
  • systolic blood pressure in mmhg(immediately after extubation and then every 5 minutes for 20 minutes)
  • mean blood pressure in mmhg(immediately after extubation and then every 5 minutes for 20 minutes)
  • oxygen saturation in %(immediately after extubation and then every 5 minutes for 20 minutes)

研究者

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

Maged Abdel-Wahab Abdel-Aziz

pricipal investigator

Cairo University

研究点 (1)

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