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

NCT04438915 | Completed DMC

• 1 other identifier: FMBSUREC/03052020/Bahr
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

Obesity; Day-case Surgery; Postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• weight ln kilograms (KG ) and Height in meters (M ) will be combined to report Body mass index (BMI ) . BMI = KG/ M^2 .

  Preoperative.

• Vital signs: HR (beat/min), MAP (mmHg) and peripheral Oxygen saturation (Spo2) %

  immediately prior to induction of anesthesia and subsequently every 5 min till the termination of anesthesia.

• Time of surgery in minutes

  Intraoperative

• AGE in years

  Preoperative

Study Arms (3)

Average weight .control group

NO INTERVENTION

Average weight BMI (18.5\_25)

Overweight

ACTIVE COMPARATOR

Overweight BMI ( 25\_30 )

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

Mild obese

ACTIVE COMPARATOR

Mild obese BMI (30\_35 )

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

Interventions

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

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

Mild obese; Overweight

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Gynecological Day- case surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aging 20\_40 years, ASA physical status I undergoing hysteroscopy procedures
• All patients can read and write well

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Faculty of medicine.Beni-suef university

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Obesity

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Amira F Elgaml

  Faculty of medicine.Beni-suef university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The doctor who ask the MMS is not informed about the design of the study .
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Anaesthesia , Surgical ICU and Pain management department . Faculty of medicine .

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 19, 2020
• Study Start: December 1, 2020
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months
• Access Criteria: The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological Day- case surgery

Locations

EG (1)