The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day Case Surgery
Primary Purpose
Postoperative Cognitive Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Postoperative Cognitive Dysfunction focused on measuring Obesity, Day-case Surgery, Postoperative cognitive dysfunction
Eligibility Criteria
Inclusion Criteria:
- Patients aging 20_40 years, ASA physical status I undergoing hysteroscopy procedures
- All patients can read and write well
Exclusion Criteria:
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
Sites / Locations
- Faculty of medicine.Beni-suef university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Average weight .control group
Overweight
Mild obese
Arm Description
Average weight BMI (18.5_25)
Overweight BMI ( 25_30 )
Mild obese BMI (30_35 )
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Vital signs: HR (beat/min), MAP (mmHg) and peripheral Oxygen saturation (Spo2) %
To make other factors irrelevant
Time of surgery in minutes
To make other factors irrelevant
AGE in years
To make other factors irrelevant
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04438915
Brief Title
The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day Case Surgery
Official Title
The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day-case Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
May 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
Obesity, Day-case Surgery, Postoperative cognitive dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The doctor who ask the MMS is not informed about the design of the study .
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Average weight .control group
Arm Type
No Intervention
Arm Description
Average weight BMI (18.5_25)
Arm Title
Overweight
Arm Type
Active Comparator
Arm Description
Overweight BMI ( 25_30 )
Arm Title
Mild obese
Arm Type
Active Comparator
Arm Description
Mild obese BMI (30_35 )
Intervention Type
Behavioral
Intervention Name(s)
Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery
Intervention Description
The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological day-case surgery
Primary Outcome Measure Information:
Title
Postoperative cognitive dysfunction( POCD )
Description
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.
Time Frame
1 hour Preoperative _ then 1 hour , 6 hours and 24 hour postoperatively
Secondary Outcome Measure Information:
Title
weight ln kilograms (KG ) and Height in meters (M ) will be combined to report Body mass index (BMI ) . BMI = KG/ M^2 .
Description
To show the effect of obesity on POCD
Time Frame
Preoperative.
Title
Vital signs: HR (beat/min), MAP (mmHg) and peripheral Oxygen saturation (Spo2) %
Description
To make other factors irrelevant
Time Frame
immediately prior to induction of anesthesia and subsequently every 5 min till the termination of anesthesia.
Title
Time of surgery in minutes
Description
To make other factors irrelevant
Time Frame
Intraoperative
Title
AGE in years
Description
To make other factors irrelevant
Time Frame
Preoperative
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gynecological Day- case surgery
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aging 20_40 years, ASA physical status I undergoing hysteroscopy procedures
All patients can read and write well
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira F Elgaml
Organizational Affiliation
Faculty of medicine.Beni-suef university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine.Beni-suef university
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological Day- case surgery
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological Day- case surgery
IPD Sharing URL
http://www.bsu.edu.eg
Learn more about this trial
The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day Case Surgery
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