Clinical trial NCT05782946: The Effect of Heavy Smoking on Early Post Operative Cognitive Dysfunction in Senile Patients .
Official title: The Effect of Heavy Smoking on Early Post Operative Cognitive Dysfunction in Senile Patients After Urological Day-case Surgery , A Randomized Controlled Trial .
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking and POCD
Keywords: Postoperative Cognitive Dysfunction
Smoking
General Anaesthesia
Day-case surgery
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Senile patients 65 : 80 ys Chronic heavy smokers \& non smokers ASA physical status 1

Brief summary: 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 .

Detailed description: 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 .

Eligibility criteria: 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 .

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: MoCA was performed preoperative .
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 1 hour Postoperative
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 6 hours post operative .
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 24 hours post operative.
Secondary outcomes:
measure: age , in years .
timeFrame: Preoperatively
measure: heart rate ( beat / minute )
timeFrame: Preoperatively and every 15 minutes for 3 hours .
measure: Body mass index( BMI ) = weight in kg/ height in m^2 .
timeFrame: Preoperatively.
measure: Mean arterial blood pressure ,MAP, ( mmHg )
timeFrame: Preoperatively and every 15 minutes for 3 hours .
measure: peripheral oxygen saturation (Spo2)
timeFrame: Preoperatively and every 15 minutes for 3 hours .
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine.Beni-suef university
Study officials:
affiliation: Faculty of Medicine Beni-Suef University Egypt
name: Mahmoud H Bahr
role: PRINCIPAL_INVESTIGATOR
References: