Postoperative Cognitive DysfunctionNCT05843838
The Effect of Intraoperative Hypotension on Postoperative Cognitive Functions in Cesarean Section Operations
A study testing Hypotension during spinal anesthesia for cesarean section, Mini-mental test and Spinal anesthesia in people with Postoperative Cognitive Dysfunction, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to see whether the hypotension that develops during spinal anesthesia in cesarean section patients causes a decrease in the postoperative cognitive functions of the patient. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Hypotension during spinal anesthesia for cesarean section, Mini-mental test and Spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 May 2024
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients between the ages of 18-40 in the ASA2, 3rd categories who will undergo cesarean section with spinal anesthesia who agree to participate in the study
Who cannot join
- Failure of the patient to accept
- The necessity of an additional intervention to the cesarean section
- Change of routine practices on a patient-by-patient basis with the occurrence of complications in the surgical process
- Presence of additional diseases
- Emergency cases, cases using intraoperative sedation
- Those who do not speak the language
- Those who have an initial Mini Mental Test score lower than 24
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara
nihan aydın güzey, 05056496231, nihanaydinguzey@gmail.com
Esra Uyar Türkyılmaz
About this study
The aim of the study is to see whether the hypotension that develops during spinal anesthesia in cesarean section patients causes a decrease in the postoperative cognitive functions of the patient. If the results show a decrease in functions due to the effect of hypotension, it will be necessary to carry out aggressive prevention/treatment of hypotension in cesarean section patients.
Read the detailed description
A total of 150 female patients (75 in each group) between the ages of 18-40 who will undergo caesarean section with spinal anesthesia in the obstetric operating room of Ankara Bilkent City Hospital in ASA 2, 3rd categories will be included in the study.
Patients will be divided into two as hypotensive and non-hypotensive patients in spinal anesthesia with routine doses, and all patients will be given a mini mental test at preop and post op 1st hour. (Hypotension, MAP(mean artery pressure)<65 mmHg, or SAP(systemic arterial pressure) < 30% will be considered as an initial value.) Patients who are hypotensive and need ephedrine will be included in the hypotensive group, and patients without hypotension will be included in the normotensive group. Those with an initial mini mental test score below 24 will not be allowed to study. At the end of the research, the mental test scores of the two groups will be compared and the effect of hypotension will be evaluated.
The patient's name-surname, age, protocol number, indication for cesarean section, method of regional anesthesia applied, sensory block level, Bromage score, side effect follow-up, first ten minutes after the procedure, every two minutes, up to half an hour, and every fifteen minutes after thirty minutes, systolic artery pressure, diastolic artery pressure, average arterial pressure, pulse and ephedrine (if used) will be recorded.
Preoperative, Postoperative first hour Mini Mental Test Score will be administered and recorded
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Hypotension during spinal anesthesia for cesarean section, Mini-mental test, Spinal anesthesia, The Bromage scale, Heavy Bupivacaine for spinal anesthesia
- Keywords
- cesarean section, postoperative cognitive dysfunction, hypotension
- Medical subject headings
- Postoperative Cognitive Complications, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotension during spinal anesthesia for cesarean sectionProcedure or surgery
Hypotension, Mean Arterial Pressure<65 mmHg, or Systolic arterial pressure < 30% will be considered an initial value
Mini-mental testDiagnostic test
A Mini-Mental State test is a set of questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory).
At the end of the research, the mental test scores of the two groups will be compared and the effect of hypotension will be evaluated.
Spinal anesthesiaProcedure or surgery
It is a neuraxial anesthesia technique in which local anesthetic is placed directly in the intrathecal space. Spinal anesthesia will be applied to both groups with heavy bupivacaine in usual doses.
The Bromage scaleDiagnostic test
The Bromage scale is the accepted tool for motor block examination. The classification of these scores
- complete block: unable to move feet or knees
- almost complete: able to move feet only
- partial: just able to flex knees; free movement of feet
- no block: full movement of knees and feet
Heavy Bupivacaine for spinal anesthesiaDrug
Routine clinical heavy bupivacaine doses
| Study group | Role | What they receive |
|---|---|---|
| Hypotensive group | Experimental | Patients who are hypotensive (even once) and need ephedrine under spinal anesthesia with routine doses of heavy bupivacaine (Hypotension, Mean Arterial Pressure<65 mmHg, or Systolic arterial pressure < 30% will be considered an initial value.) Receives: Procedure: Hypotension during spinal anesthesia for cesarean section; Diagnostic Test: Mini-mental test; Procedure: Spinal anesthesia; Diagnostic Test: The Bromage scale; Drug: Heavy Bupivacaine for spinal anesthesia |
| Normotensive group | Placebo comparator | Patients who are not hypotensive under spinal anesthesia with routine doses of heavy bupivacaine Receives: Diagnostic Test: Mini-mental test; Procedure: Spinal anesthesia; Diagnostic Test: The Bromage scale; Drug: Heavy Bupivacaine for spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative cognitive function related with hypotension in cesarean section
Postoperative cognitive dysfunction is defined as the decrease in postoperative 1st hour mini-mental test results compared to preoperative results.Higher scores of mini-mental test mean a better outcome.By comparing the difference between the preoperative and postoperative mini-mental test results of the patients in the two arms, It will be observed whether there is a cognitive function difference between the groups.
Measured: Preoperative (in 10 minutes before operation) to postoperative first hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Feb 2024
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- esra uyar türkyılmaz, Principal investigator, Ankara Bilkent City Hospital Ankara Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843838
- Sponsor's protocol ID
- E2-23-3719
- Status last verified
- Feb 2024
- First submitted
- 13 Apr 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Hypotension on Postoperative Cognitive Functions in Cesarean Section Operations
- ClinicalTrials.gov ID
- NCT05843838
- Acronym / sponsor ID
- E2-23-3719
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- cesarean section, postoperative cognitive dysfunction, hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 6 May 2023 (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.
The aim of the study is to see whether the hypotension that develops during spinal anesthesia in cesarean section patients causes a decrease in the postoperative cognitive functions of the patient. If the results show a decrease in functions due to the effect of hypotension, it will be necessary to carry out aggressive prevention/treatment of hypotension in cesarean section patients.
Detailed description
A total of 150 female patients (75 in each group) between the ages of 18-40 who will undergo caesarean section with spinal anesthesia in the obstetric operating room of Ankara Bilkent City Hospital in ASA 2, 3rd categories will be included in the study.
Patients will be divided into two as hypotensive and non-hypotensive patients in spinal anesthesia with routine doses, and all patients will be given a mini mental test at preop and post op 1st hour. (Hypotension, MAP(mean artery pressure)<65 mmHg, or SAP(systemic arterial pressure) < 30% will be considered as an initial value.) Patients who are hypotensive and need ephedrine will be included in the hypotensive group, and patients without hypotension will be included in the normotensive group. Those with an initial mini mental test score below 24 will not be allowed to study. At the end of the research, the mental test scores of the two groups will be compared and the effect of hypotension will be evaluated.
The patient's name-surname, age, protocol number, indication for cesarean section, method of regional anesthesia applied, sensory block level, Bromage score, side effect follow-up, first ten minutes after the procedure, every two minutes, up to half an hour, and every fifteen minutes after thirty minutes, systolic artery pressure, diastolic artery pressure, average arterial pressure, pulse and ephedrine (if used) will be recorded.
Preoperative, Postoperative first hour Mini Mental Test Score will be administered and recorded
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotensive group | Experimental | Procedure: Hypotension during spinal anesthesia for cesarean section, Diagnostic Test: Mini-mental test, Procedure: Spinal anesthesia, Diagnostic Test: The Bromage scale, Drug: Heavy Bupivacaine for spinal anesthesiaPatients who are hypotensive (even once) and need ephedrine under spinal anesthesia with routine doses of heavy bupivacaine (Hypotension, Mean Arterial Pressure<65 mmHg, or Systolic arterial pressure < 30% will be considered an initial value.) |
| Normotensive group | Placebo comparator | Diagnostic Test: Mini-mental test, Procedure: Spinal anesthesia, Diagnostic Test: The Bromage scale, Drug: Heavy Bupivacaine for spinal anesthesiaPatients who are not hypotensive under spinal anesthesia with routine doses of heavy bupivacaine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients between the ages of 18-40 in the ASA2, 3rd categories who will undergo cesarean section with spinal anesthesia who agree to participate in the study
Key exclusion criteria (7 listed)
- Failure of the patient to accept
- The necessity of an additional intervention to the cesarean section
- Change of routine practices on a patient-by-patient basis with the occurrence of complications in the surgical process
- Presence of additional diseases
- Emergency cases, cases using intraoperative sedation
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 |
|---|---|---|
| Hypotension during spinal anesthesia for cesarean sectionHypotension, Mean Arterial Pressure<65 mmHg, or Systolic arterial pressure < 30% will be considered an initial value | Procedure or surgery | Hypotensive group |
| Mini-mental testA Mini-Mental State test is a set of questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). At the end of the research, the mental test scores of the two groups will be compared and the effect of hypotension will be evaluated. | Diagnostic test | Hypotensive group, Normotensive group |
| Spinal anesthesiaIt is a neuraxial anesthesia technique in which local anesthetic is placed directly in the intrathecal space. Spinal anesthesia will be applied to both groups with heavy bupivacaine in usual doses. | Procedure or surgery | Hypotensive group, Normotensive group |
| The Bromage scaleThe Bromage scale is the accepted tool for motor block examination. The classification of these scores 1. complete block: unable to move feet or knees 2. almost complete: able to move feet only 3. partial: just able to flex knees; free movement of feet 4. no block: full movement of knees and feet | Diagnostic test | Hypotensive group, Normotensive group |
| Heavy Bupivacaine for spinal anesthesiaRoutine clinical heavy bupivacaine doses | Drug | Hypotensive group, Normotensive group |
Primary outcome
Change in postoperative cognitive function related with hypotension in cesarean section
Time frame: Preoperative (in 10 minutes before operation) to postoperative first hour.
Postoperative cognitive dysfunction is defined as the decrease in postoperative 1st hour mini-mental test results compared to preoperative results.Higher scores of mini-mental test mean a better outcome.By comparing the difference between the preoperative and postoperative mini-mental test results of the patients in the two arms, It will be observed whether there is a cognitive function difference between the groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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.
esra uyar türkyılmaz principal investigator
Ankara Bilkent City Hospital Ankara Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypotension during spinal anesthesia for cesarean section, Mini-mental test and Spinal anesthesia in people with Postoperative Cognitive Dysfunction, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nihan aydın güzey (+90 505 6496231, nihanaydinguzey@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postoperative cognitive function related with hypotension in cesarean section (time frame: Preoperative (in 10 minutes before operation) to postoperative first hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.