The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day Case Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Cognitive Dysfunction
• Intervention / Treatment: Behavioral: Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery

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 Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Faculty of medicine.Beni-suef university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Average weight .control group; Average weight BMI (18.5_25)
Active Comparator: Overweight; Overweight BMI ( 25_30 )	Behavioral: Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery; The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological day-case surgery
Active Comparator: Mild obese; Mild obese BMI (30_35 )	Behavioral: Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery; The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological day-case surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour Preoperative _ then 1 hour , 6 hours and 24 hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Preoperative.
Vital signs: HR (beat/min), MAP (mmHg) and peripheral Oxygen saturation (Spo2) %	To make other factors irrelevant	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	Intraoperative
AGE in years	To make other factors irrelevant	Preoperative

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Study Director: Amira F Elgaml, Faculty of medicine.Beni-suef university

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): May 20, 2021

Study Registration Dates

• First Submitted: June 6, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Postoperative cognitive dysfunction; Day-case Surgery
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Cognition Disorders; Obesity; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: FMBSUREC/03052020/Bahr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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