Effect of General Anesthesia on Early Postoperative Cognitive Function in Cesarean Section

November 16, 2020 updated by: Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

Effect of General Anesthesia on Early Postoperative Cognitive Dysfunction in Elective Versus Emergency Cesarean Section

Cognitive dysfunction is the impairment of the mental process of perception, memory and information processing. The preoperative cognitive state is important, as mild cognitive impairment may be worsened following a cesarean section. Our study will aim to assess the incidence of early cognitive dysfunction after elective and emergent cesarean section under general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mechanisms that lead to cognitive decline after anesthesia and surgery remain still unclear and mixed. Some studies suggested that an important role is played by the immune response to surgery. The inflammatory response could contribute to the development of postoperative cognitive decline (POCD0 through secretion of cortisol, cytokines, and other inflammatory mediators. Comparing the effects of general and spinal anesthesia on pregnant patients undergoing an elective cesarean section, found no cognitive change after both anesthesias. Our observational comparative study will be carried out at Beni Suef University Hospital. We will compare early cognitive functions undergoing general anesthesia in patients undergoing elective and emergency cesarean section.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Nesreen Abdel Fattah Abdullah Shehata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women in reproductive age period between 25 and 35 years booked for an elective or emergency cesarean section.

Description

Inclusion Criteria:

  • Women in reproductive age period between 25 and 35 years
  • Women booked for an elective or emergency cesarean section.

Exclusion Criteria:

  • Mental disorder preoperative
  • Medical conditions ( as Hypertension or diabetes or cardiac diseases)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
women undergoing elective CS under general anesthesia
Early postoperative assessment of the cognitive function of patients through evaluation document which will be filled by the anesthesiologist.
Other: Assessment document
The anesthesiologist will evaluate through his sheet women's cognitive functions.
Other Names:
  • Anesthesiologist evaluation sheet
women undergoing emergency CS under general anesthesia
Early postoperative assessment of the cognitive function of patients through evaluation document which will be filled by the anesthesiologist.
Other: Assessment document
The anesthesiologist will evaluate through his sheet women's cognitive functions.
Other Names:
  • Anesthesiologist evaluation sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative cognitive decline (POCD)
Time Frame: 3 hours postoperative
New impairment of memory directly post operative which will be assessed by psychometric questionnaire
3 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impaired performance on intellectual tasks
Time Frame: 3 days postoperative
New impairment of using mind in daily tasks directly post operative which will be assessed through a questionnaire
3 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2019

Primary Completion (Actual)

September 20, 2020

Study Completion (Actual)

September 20, 2020

Study Registration Dates

First Submitted

January 20, 2019

First Submitted That Met QC Criteria

January 23, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Beni-Suef 17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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