Postoperative Cognitive DysfunctionNCT04438915
The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day Case Surgery
A study testing Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery in people with Postoperative Cognitive Dysfunction, 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 Post operative 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 20 to 40 years, women only
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 20 May 2021
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients aging 20_40 years, ASA physical status I undergoing hysteroscopy procedures
- All patients can read and write well
Who cannot join
- Patients not ASA1 Patients receiving sedatives as midazolam. Pregnant Patients . Patients with cerebrovascular diseases . Patients with history of allergy to the drugs used in the study 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 fluid volume more than 1500 ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day-case Surgery
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 Post operative cognitive dysfunction (POCD) is unclear and seems to be multifactorial involving a combination of patient, surgical, anesthetic and environmental factors. The definition of day surgery in Great Britain and Ireland is clear; the patient is admitted and discharged on the same day.
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 Post operative 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 overmonths 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.
The overweight/obese population has been steadily increasing worldwide. According to the WHO, with1.3 billion overweight (25 < body mass index [BMI] < 30) people and 600 million obese (BMI > 30) people in the world, the obesity rate exceeds10% for both genders and has more than doubled during the past 40 years. Furthermore, It considered as seven of the top10 causes of death / physical disability and chronic disorders such as cancer and diabetes, which are closely related to obesity.
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. Obesity itself is not a contraindication to day surgery, as morbidly obese patients can be safely managed by experts, provided appropriate resources are available. This includes factoring in additional time for anaesthesia and surgery as well as the presence of skilled assistants and equipment.
The incidence of complications during the operation or in the early recovery phase is greater in patients with increasing body mass index. However, these problems would still occur with inpatient care and have usually resolved or been successfully treated by the time a day-case patient would be discharged. In addition, obese patients benefit from short-duration anaesthetic techniques and early mobilisation associated with day surgery.
Our study will aim to assess the early cognitive dysfunction after general anesthesia in normal weight patients, overweight and mild obese patients in gynacological day-case surgery.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery
- Keywords
- Obesity, Day-case Surgery, Postoperative cognitive dysfunction
- Medical subject headings
- Postoperative Cognitive Complications, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgeryBehavioural
The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological day-case surgery
| Study group | Role | What they receive |
|---|---|---|
| Average weight .control group | No intervention | Average weight BMI (18.5_25) |
| Overweight | Active comparator | Overweight BMI ( 25_30 ) Receives: Behavioral: Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery |
| Mild obese | Active comparator | Mild obese BMI (30_35 ) Receives: Behavioral: Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognitive dysfunction( POCD )
Mini Mental State a practical method for grading the cognitive state ( Max score 30 degree ) Orientation 10 degree , Registration 3 degree , Attention\&Calculation 5 degree , Recall 3 degree , language 9 degree .
Decrease 2 or more than Preoperative score will indicate POCD.
Measured: 1 hour Preoperative _ then 1 hour , 6 hours and 24 hour postoperatively
Secondary outcomes (4)
weight ln kilograms (KG ) and Height in meters (M ) will be combined to report Body mass index (BMI ) . BMI = KG/ M^2 .
To show the effect of obesity on POCD
Measured: Preoperative.
Vital signs: HR (beat/min), MAP (mmHg) and peripheral Oxygen saturation (Spo2) %
To make other factors irrelevant
Measured: immediately prior to induction of anesthesia and subsequently every 5 min till the termination of anesthesia.
Time of surgery in minutes
To make other factors irrelevant
Measured: Intraoperative
AGE in years
To make other factors irrelevant
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Dec 2020
- Primary completion20 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 138 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
- Amira F Elgaml, Study director, Faculty of medicine.Beni-suef university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438915
- Sponsor's protocol ID
- FMBSUREC/03052020/Bahr
- Status last verified
- Apr 2021
- First submitted
- 6 Jun 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological Day- case surgery
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day-case Surgery
- ClinicalTrials.gov ID
- NCT04438915
- Acronym / sponsor ID
- FMBSUREC/03052020/Bahr
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Obesity, Day-case Surgery, Postoperative cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 19 Jun 2020 (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 Post operative cognitive dysfunction (POCD) is unclear and seems to be multifactorial involving a combination of patient, surgical, anesthetic and environmental factors. The definition of day surgery in Great Britain and Ireland is clear; the patient is admitted and discharged on the same day.
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 Post operative 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 overmonths 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.
The overweight/obese population has been steadily increasing worldwide. According to the WHO, with1.3 billion overweight (25 < body mass index [BMI] < 30) people and 600 million obese (BMI > 30) people in the world, the obesity rate exceeds10% for both genders and has more than doubled during the past 40 years. Furthermore, It considered as seven of the top10 causes of death / physical disability and chronic disorders such as cancer and diabetes, which are closely related to obesity.
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. Obesity itself is not a contraindication to day surgery, as morbidly obese patients can be safely managed by experts, provided appropriate resources are available. This includes factoring in additional time for anaesthesia and surgery as well as the presence of skilled assistants and equipment.
The incidence of complications during the operation or in the early recovery phase is greater in patients with increasing body mass index. However, these problems would still occur with inpatient care and have usually resolved or been successfully treated by the time a day-case patient would be discharged. In addition, obese patients benefit from short-duration anaesthetic techniques and early mobilisation associated with day surgery.
Our study will aim to assess the early cognitive dysfunction after general anesthesia in normal weight patients, overweight and mild obese patients in gynacological day-case surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Average weight .control group | No intervention | –Average weight BMI (18.5_25) |
| Overweight | Active comparator | Behavioral: Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgeryOverweight BMI ( 25_30 ) |
| Mild obese | Active comparator | Behavioral: Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgeryMild obese BMI (30_35 ) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aging 20_40 years, ASA physical status I undergoing hysteroscopy procedures
- All patients can read and write well
Key exclusion criteria (2 listed)
- Patients not ASA1 Patients receiving sedatives as midazolam. Pregnant Patients . Patients with cerebrovascular diseases . Patients with history of allergy to the drugs used in the study 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 fluid volume more than 1500 ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgeryThe effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological day-case surgery | Behavioural | Mild obese, Overweight |
Primary outcome
Postoperative cognitive dysfunction( POCD )
Time frame: 1 hour Preoperative _ then 1 hour , 6 hours and 24 hour postoperatively
Mini Mental State a practical method for grading the cognitive state ( Max score 30 degree ) Orientation 10 degree , Registration 3 degree , Attention\&Calculation 5 degree , Recall 3 degree , language 9 degree . Decrease 2 or more than Preoperative score will indicate POCD.
4 secondary outcomes
weight ln kilograms (KG ) and Height in meters (M ) will be combined to report Body mass index (BMI ) . BMI = KG/ M^2 .
Time frame: Preoperative.
Vital signs: HR (beat/min), MAP (mmHg) and peripheral Oxygen saturation (Spo2) %
Time frame: immediately prior to induction of anesthesia and subsequently every 5 min till the termination of anesthesia.
Time of surgery in minutes
Time frame: Intraoperative
AGE in years
Time frame: Preoperative
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 20 Jul 2021.
- Individual participant dataSharing planned: Yes. The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological Day- case surgery
Related trials for Postoperative Cognitive Dysfunction
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
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Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
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.
Amira F Elgaml study director
Faculty of medicine.Beni-suef university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery in people with Postoperative Cognitive Dysfunction, 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 2 inclusion and 2 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 20 Jul 2021. 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?
Postoperative cognitive dysfunction( POCD ) (time frame: 1 hour Preoperative _ then 1 hour , 6 hours and 24 hour postoperatively). 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 20 Jul 2021.