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

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT04438915
Collaborator
(none)
138
1
3
5.6
24.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery
N/A

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

Study Type:
Interventional
Actual Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
The doctor who ask the MMS is not informed about the design of the study .
Primary Purpose:
Diagnostic
Official Title:
The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day-case Surgery
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
May 20, 2021
Actual Study Completion Date :
May 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Postoperative cognitive dysfunction( POCD ) [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.

Secondary Outcome Measures

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

    To show the effect of obesity on POCD

  2. 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.]

    To make other factors irrelevant

  3. Time of surgery in minutes [Intraoperative]

    To make other factors irrelevant

  4. AGE in years [Preoperative]

    To make other factors irrelevant

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of medicine.Beni-suef university Cairo Egypt 11865

Sponsors and Collaborators

  • Beni-Suef University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud Hussein Bahr, Lecturer in Anaesthesia , Surgical ICU and Pain management department . Faculty of medicine ., Beni-Suef University
ClinicalTrials.gov Identifier:
NCT04438915
Other Study ID Numbers:
  • FMBSUREC/03052020/Bahr
First Posted:
Jun 19, 2020
Last Update Posted:
Jul 20, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mahmoud Hussein Bahr, Lecturer in Anaesthesia , Surgical ICU and Pain management department . Faculty of medicine ., Beni-Suef University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021