跳至主要内容
临床试验/NCT05782946
NCT05782946已完成不适用

The Effect of Heavy Smoking on Early Post Operative Cognitive Dysfunction in Senile Patients After Urological Day-case Surgery , A Randomized Controlled Trial .

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年4月1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
110
试验地点
1
主要终点
Montreal Cognitive Assessment (MoCA)

研究概览

简要总结

Cognitive dysfunction is the impairment of mental process of perception, memory and information processing which allow the human to acquire knowledge and plan for the future . The etiology of Postoperative cognitive dysfunction (POCD) is unclear and seems to be multifactorial involving a combination of patient, surgical, anesthetic and environmental factors .It can be a manifestation of transient or permanent cerebral injury. While cognitive function tends to improve over months to years postoperatively in affected individuals, some proportion has seemingly permanent cognitive injury .

详细描述

Cognitive dysfunction is the impairment of mental process of perception, memory and information processing which allow the human to acquire knowledge and plan for the future . The etiology of Postoperative cognitive dysfunction (POCD) is unclear and seems to be multifactorial involving a combination of patient, surgical, anesthetic and environmental factors .It can be a manifestation of transient or permanent cerebral injury. While cognitive function tends to improve over months to years postoperatively in affected individuals, some proportion has seemingly permanent cognitive injury .

Most of the studies of POCD, however, have methodological difficulties, as pointed out by Newman and colleagues in their review of more than 40 studies . a major difficulty in trying to compare investigations or establish an incidence of POCD was the diversity in participants, types of surgery and anesthesia, methods of assessment, definition of POCD, and mode of analysis .

The number of tobacco smokers has been decreasing over the last decade in most Western countries, while the percentage of smokers is still increasing in some developing countries . Tobacco smoking is still one of the major causes of mortality and morbidity worldwide . In particular, it is well known that smoking is strongly associated with cardiovascular diseases, pulmonary diseases and cancer. In addition, it is also thought that smoking could increase the risk of poor postoperative outcomes, in ways including impaired wound healing ، infections and cardiopulmonary complications.

The definition of day surgery in Great Britain and Ireland is clear; the patient is admitted and discharged on the same day, with day surgery as the intended management. The term '23-h stay' is used in the United states healthcare system .

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
65 Years 至 80 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients between 65 & 80 ys
  • elective urological day-case surgery
  • ASA physical status 1

排除标准

  • Patients not ASA1
  • Patients receiving sedatives as midazolam.
  • Pregnant Patients .
  • Patients with cerebrovascular diseases .
  • Patients with history of drug allergy or patients with substance abuse .
  • Time of anesthesia less than 30 minute ,or more than one hour .
  • Irrigation fluid rather than warm saline(40 degree ) or volume more than 1500 ml
  • post- secondary Education level .

结局指标

主要结局

Montreal Cognitive Assessment (MoCA)

时间窗: 24 hours post operative.

Montreal Cognitive Assessment (MoCA) MoCA was a questionnaire performed preoperative then post operative . The MoCA used in this study was developed by Professor Nasreddine in 2004 and is used for the rapid screening assessment of mild cognitive impairment. The cognitive areas assessed by MoCA included attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, calculation and orientation. The scale had a total score of 30 points. ≥26 points were considered as having no cognitive impairment .

次要结局

  • peripheral oxygen saturation (Spo2)(Preoperatively and every 15 minutes for 3 hours .)
  • age , in years .(Preoperatively)
  • heart rate ( beat / minute )(Preoperatively and every 15 minutes for 3 hours .)
  • Body mass index( BMI ) = weight in kg/ height in m^2 .(Preoperatively.)
  • Mean arterial blood pressure ,MAP, ( mmHg )(Preoperatively and every 15 minutes for 3 hours .)

研究者

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

Mahmoud Hussein Bahr

Associated Professor of Anesthesiology and Surgical Intensive Care and pain medicine

Beni-Suef University

研究点 (1)

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