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Completed

NCT Number: NCT05782946

The Effect of Heavy Smoking on Early Post Operative Cognitive Dysfunction in Senile Patients .

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 .

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine.Beni-suef university

Cairo, 62511, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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 .

Treatment and study plan

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: MoCA was performed preoperative .

    Montreal Cognitive Assessment (MoCA) MoCA was a questionaire 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 .

  2. Montreal Cognitive Assessment (MoCA)

    Time frame: 1 hour Postoperative

    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 .

  3. Montreal Cognitive Assessment (MoCA)

    Time frame: 6 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 .

  4. Montreal Cognitive Assessment (MoCA)

    Time frame: 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 .

Secondary outcomes

  1. age , in years .

    Time frame: Preoperatively

    age , in years .

  2. heart rate ( beat / minute )

    Time frame: Preoperatively and every 15 minutes for 3 hours .

    heart rate ( beat / minute )

  3. Body mass index( BMI ) = weight in kg/ height in m^2 .

    Time frame: Preoperatively.

    Body mass index( BMI ) = weight in kg/ height in m^2 .

  4. Mean arterial blood pressure ,MAP, ( mmHg )

    Time frame: Preoperatively and every 15 minutes for 3 hours .

    Mean arterial blood pressure ,MAP, ( mmHg )

  5. peripheral oxygen saturation (Spo2)

    Time frame: Preoperatively and every 15 minutes for 3 hours .

    peripheral oxygen saturation (Spo2)

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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