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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.) |
|
| Normotensive group | Placebo Comparator | Patients who are not hypotensive under spinal anesthesia with routine doses of heavy bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypotension during spinal anesthesia for cesarean section | Procedure | Hypotension, Mean Arterial Pressure<65 mmHg, or Systolic arterial pressure < 30% will be considered an initial value |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperative (in 10 minutes before operation) to postoperative first hour. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| nihan aydın güzey | Contact | +90 505 6496231 | nihanaydinguzey@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| esra uyar türkyılmaz | Ankara Bilkent City Hospital Ankara Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Recruiting | Ankara | Turkey (Türkiye) |
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| Mini-mental test | Diagnostic 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 anesthesia | Procedure | 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 scale | Diagnostic Test | The Bromage scale is the accepted tool for motor block examination. The classification of these scores
|
|
| Heavy Bupivacaine for spinal anesthesia | Drug | Routine clinical heavy bupivacaine doses |
|
| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002585 | Cesarean Section |
| D000775 | Anesthesia, Spinal |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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