Effect of General Anesthesia on Early Postoperative Cognitive Function in Cesarean Section
1 other identifier
observational
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2019
CompletedFirst Submitted
Initial submission to the registry
January 20, 2019
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2020
CompletedNovember 17, 2020
November 1, 2020
1.7 years
January 20, 2019
November 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative cognitive decline (POCD)
New impairment of memory directly post operative which will be assessed by psychometric questionnaire
3 hours postoperative
Secondary Outcomes (1)
impaired performance on intellectual tasks
3 days postoperative
Study Arms (2)
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.
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.
Interventions
The anesthesiologist will evaluate through his sheet women's cognitive functions.
Eligibility Criteria
Women in reproductive age period between 25 and 35 years booked for an elective or emergency cesarean section.
You may qualify if:
- Women in reproductive age period between 25 and 35 years
- Women booked for an elective or emergency cesarean section.
You may not qualify if:
- Mental disorder preoperative
- Medical conditions ( as Hypertension or diabetes or cardiac diseases)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nesreen Abdel Fattah Abdullah Shehata
Cairo, Egypt
Related 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 related to post-operative cognitive dysfunction? Acta Anaesthesiol Scand. 2005 Oct;49(9):1225-31. doi: 10.1111/j.1399-6576.2005.00791.x.
PMID: 16146456RESULTWan 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. doi: 10.1097/00000542-200703000-00007.
PMID: 17325501RESULT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
January 20, 2019
First Posted
January 28, 2019
Study Start
January 14, 2019
Primary Completion
September 20, 2020
Study Completion
September 20, 2020
Last Updated
November 17, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share