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

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT03818009
Collaborator
(none)
58
Enrollment
1
Location
20.2
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Assessment document

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 Design

Study Type:
Observational
Actual Enrollment :
58 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of General Anesthesia on Early Postoperative Cognitive Dysfunction in Elective Versus Emergency Cesarean Section
Actual Study Start Date :
Jan 14, 2019
Actual Primary Completion Date :
Sep 20, 2020
Actual Study Completion Date :
Sep 20, 2020

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative cognitive decline (POCD) [3 hours postoperative]

      New impairment of memory directly post operative which will be assessed by psychometric questionnaire

    Secondary Outcome Measures

    1. impaired performance on intellectual tasks [3 days postoperative]

      New impairment of using mind in daily tasks directly post operative which will be assessed through a questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nesreen Abdel Fattah Abdullah Shehata Cairo Egypt

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nesreen Abdel Fattah Abdullah Shehata, Assistant professor, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT03818009
    Other Study ID Numbers:
    • Beni-Suef 17
    First Posted:
    Jan 28, 2019
    Last Update Posted:
    Nov 17, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nesreen Abdel Fattah Abdullah Shehata, Assistant professor, Beni-Suef University
    Cognitive function postoperative

    Study Results

    No Results Posted as of Nov 17, 2020