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

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

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 .

Study Overview

• Status: Completed
• Conditions: Smoking and POCD

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 .

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 62511
    • Faculty of medicine.Beni-suef university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Senile patients 65 : 80 ys Chronic heavy smokers & non smokers ASA physical status 1

Description

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 .

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	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 .	MoCA was performed preoperative .
Montreal Cognitive Assessment (MoCA)	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 .	1 hour Postoperative
Montreal Cognitive Assessment (MoCA)	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 .	6 hours post operative .
Montreal Cognitive Assessment (MoCA)	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 .	24 hours post operative.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Mahmoud H Bahr, Faculty of Medicine Beni-Suef University Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Smoking; Postoperative Cognitive Dysfunction; General Anaesthesia; Day-case surgery
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: FMBSUREC/12022023/Emam

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No