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

Sponsor
Beni-Suef University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05782946
Collaborator
(none)
110
1
8
13.7

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    110 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    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 .
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Montreal Cognitive Assessment (MoCA) [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) [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) [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) [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 Outcome Measures

    1. age , in years . [Preoperatively]

      age , in years .

    2. heart rate ( beat / minute ) [Preoperatively and every 15 minutes for 3 hours .]

      heart rate ( beat / minute )

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

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

    4. Mean arterial blood pressure ,MAP, ( mmHg ) [Preoperatively and every 15 minutes for 3 hours .]

      Mean arterial blood pressure ,MAP, ( mmHg )

    5. peripheral oxygen saturation (Spo2) [Preoperatively and every 15 minutes for 3 hours .]

      peripheral oxygen saturation (Spo2)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine.Beni-suef university Cairo Egypt 62511

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmoud Hussein Bahr, Associated Professor of Anesthesiology and Surgical Intensive Care and pain medicine, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05782946
    Other Study ID Numbers:
    • FMBSUREC/12022023/Emam
    First Posted:
    Mar 24, 2023
    Last Update Posted:
    Mar 24, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahmoud Hussein Bahr, Associated Professor of Anesthesiology and Surgical Intensive Care and pain medicine, Beni-Suef University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 24, 2023