Smoking and POCDNCT05782946
The Effect of Heavy Smoking on Early Post Operative Cognitive Dysfunction in Senile Patients .
An observational study of Smoking and POCD, run by Beni-Suef University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Smoking and POCD
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Senile patients 65 : 80 ys Chronic heavy smokers \& non smokers ASA physical status 1
Who may be able to join
- patients between 65 \& 80 ys
- elective urological day-case surgery
- ASA physical status 1
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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 .
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 .
Read the 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 .
- Conditions
- Smoking and POCD
- Keywords
- Postoperative Cognitive Dysfunction, Smoking, General Anaesthesia, Day-case surgery
- Medical subject headings
- Smoking, Postoperative Cognitive Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 24 hours post operative.
Secondary outcomes (5)
age , in years .
age , in years .
Measured: Preoperatively
heart rate ( beat / minute )
heart rate ( beat / minute )
Measured: 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 .
Measured: Preoperatively.
Mean arterial blood pressure ,MAP, ( mmHg )
Mean arterial blood pressure ,MAP, ( mmHg )
Measured: Preoperatively and every 15 minutes for 3 hours .
peripheral oxygen saturation (Spo2)
peripheral oxygen saturation (Spo2)
Measured: Preoperatively and every 15 minutes for 3 hours .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking and POCDStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hussein Bahr, Beni-Suef University
- Investigators
- Mahmoud H Bahr, Principal investigator, Faculty of Medicine Beni-Suef University Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782946
- Sponsor's protocol ID
- FMBSUREC/12022023/Emam
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided yet
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 .
- ClinicalTrials.gov ID
- NCT05782946
- Acronym / sponsor ID
- FMBSUREC/12022023/Emam
- Conditions
- Smoking and POCD
- Keywords
- Postoperative Cognitive Dysfunction, Smoking, General Anaesthesia, Day-case surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Senile patients 65 : 80 ys Chronic heavy smokers \& non smokers ASA physical status 1
Key inclusion criteria (3 listed)
- patients between 65 \& 80 ys
- elective urological day-case surgery
- ASA physical status 1
Key exclusion criteria (8 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 .
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 .
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 .
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 .
5 secondary outcomes
age , in years .
Time frame: Preoperatively
heart rate ( beat / minute )
Time frame: Preoperatively and every 15 minutes for 3 hours .
Body mass index( BMI ) = weight in kg/ height in m^2 .
Time frame: Preoperatively.
Mean arterial blood pressure ,MAP, ( mmHg )
Time frame: Preoperatively and every 15 minutes for 3 hours .
peripheral oxygen saturation (Spo2)
Time frame: Preoperatively and every 15 minutes for 3 hours .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: Undecided. Undecided yet
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud H Bahr principal investigator
Faculty of Medicine Beni-Suef University Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and POCD, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: MoCA was performed preoperative .). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.