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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04438915
Enrollment
138
Registered
2020-06-19
Start date
2020-12-01
Completion date
2021-05-20
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction

Keywords

Obesity, Day-case Surgery, Postoperative cognitive dysfunction

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.

Interventions

BEHAVIORALEffect 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

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Masking description

The doctor who ask the MMS is not informed about the design of the study .

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative cognitive dysfunction( POCD )1 hour Preoperative _ then 1 hour , 6 hours and 24 hour postoperativelyMini 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

MeasureTime frameDescription
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
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
Time of surgery in minutesIntraoperativeTo make other factors irrelevant
AGE in yearsPreoperativeTo make other factors irrelevant

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026