Anesthesia MorbidityNCT03818009
Effect of General Anesthesia on Early Postoperative Cognitive Function in Cesarean Section
An observational study of Anesthesia Morbidity and Cesarean Section Complications, run by Beni-Suef University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Anesthesia Morbidity, Cesarean Section Complications
- What is being tested?
- Assessment document
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2019to 20 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Women in reproductive age period between 25 and 35 years booked for an elective or emergency cesarean section.
Who may be able to join
- Women in reproductive age period between 25 and 35 years
- Women booked for an elective or emergency cesarean section.
Who cannot join
- Mental disorder preoperative
- Medical conditions ( as Hypertension or diabetes or cardiac diseases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Assessment document
- Keywords
- Cognitive function postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment documentOther
Also called Anesthesiologist evaluation sheet
The anesthesiologist will evaluate through his sheet women's cognitive functions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Assessment document | |
| 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. Receives: Other: Assessment document |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative cognitive decline (POCD)
New impairment of memory directly post operative which will be assessed by psychometric questionnaire
Measured: 3 hours postoperative
Secondary outcomes (1)
impaired performance on intellectual tasks
New impairment of using mind in daily tasks directly post operative which will be assessed through a questionnaire
Measured: 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start14 Jan 2019
- Primary completion20 Sep 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818009
- Sponsor's protocol ID
- Beni-Suef 17
- Status last verified
- Nov 2020
- First submitted
- 20 Jan 2019
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16146456Wan 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.
PubMed 17325501
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of General Anesthesia on Early Postoperative Cognitive Dysfunction in Elective Versus Emergency Cesarean Section
- ClinicalTrials.gov ID
- NCT03818009
- Acronym / sponsor ID
- Beni-Suef 17
- Keywords
- Cognitive function postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women undergoing elective CS under general anesthesia | – | Other: Assessment documentEarly 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 | – | Other: Assessment documentEarly postoperative assessment of the cognitive function of patients through evaluation document which will be filled by the anesthesiologist. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women in reproductive age period between 25 and 35 years booked for an elective or emergency cesarean section.
Key inclusion criteria (2 listed)
- Women in reproductive age period between 25 and 35 years
- Women booked for an elective or emergency cesarean section.
Key exclusion criteria (2 listed)
- Mental disorder preoperative
- Medical conditions ( as Hypertension or diabetes or cardiac diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment documentAlso: Anesthesiologist evaluation sheetThe anesthesiologist will evaluate through his sheet women's cognitive functions. | Other | women undergoing elective CS under general anesthesia, women undergoing emergency CS under general anesthesia |
Primary outcome
postoperative cognitive decline (POCD)
Time frame: 3 hours postoperative
New impairment of memory directly post operative which will be assessed by psychometric questionnaire
1 secondary outcome
impaired performance on intellectual tasks
Time frame: 3 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Results publication: PubMed 16146456Rasmussen 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.
- Results publication: PubMed 17325501Wan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Morbidity and Cesarean Section Complications, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative cognitive decline (POCD) (time frame: 3 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03818009, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.