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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03818009
Other study ID # Beni-Suef 17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 14, 2019
Est. completion date September 20, 2020

Study information

Verified date November 2020
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date September 20, 2020
Est. primary completion date September 20, 2020
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment document
The anesthesiologist will evaluate through his sheet women's cognitive functions.

Locations

Country Name City State
Egypt Nesreen Abdel Fattah Abdullah Shehata Cairo

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Rasmussen LS, O'Brien JT, Silverstein JH, Johnson TW, Siersma VD, Canet J, Jolles J, Hanning CD, Kuipers HM, Abildstrom H, Papaioannou A, Raeder J, Yli-Hankala A, Sneyd JR, Munoz L, Moller JT; ISPOCD2 Investigators. Is peri-operative cortisol secretion re — View Citation

Wan Y, Xu J, Ma D, Zeng Y, Cibelli M, Maze M. Postoperative impairment of cognitive function in rats: a possible role for cytokine-mediated inflammation in the hippocampus. Anesthesiology. 2007 Mar;106(3):436-43. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative cognitive decline (POCD) New impairment of memory directly post operative which will be assessed by psychometric questionnaire 3 hours postoperative
Secondary impaired performance on intellectual tasks New impairment of using mind in daily tasks directly post operative which will be assessed through a questionnaire 3 days postoperative
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