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

NCT ID: NCT04438915

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-05-20

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.

Conditions

Postoperative Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Average weight .control group

Average weight BMI (18.5\_25)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Overweight

Overweight BMI ( 25\_30 )

Group Type: ACTIVE_COMPARATOR

Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery

Intervention Type: BEHAVIORAL

The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological day-case surgery

Mild obese

Mild obese BMI (30\_35 )

Group Type: ACTIVE_COMPARATOR

Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery

Intervention Type: BEHAVIORAL

The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological day-case surgery

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Hussein Bahr

Lecturer in Anaesthesia , Surgical ICU and Pain management department . Faculty of medicine .

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amira F Elgaml

Role: STUDY_DIRECTOR

Faculty of medicine.Beni-suef university

Locations

Faculty of medicine.Beni-suef university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMBSUREC/03052020/Bahr

Identifier Type: -

Identifier Source: org_study_id