The Effect of Intraoperative Hypotension on Postoperative Cognitive Functions in Cesarean Section Operations
NCT ID: NCT05843838
Last Updated: 2024-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-02-01
2024-05-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Hypotensive group
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.)
Hypotension during spinal anesthesia for cesarean section
Hypotension, Mean Arterial Pressure\<65 mmHg, or Systolic arterial pressure \< 30% will be considered an initial value
Mini-mental 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
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
The 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
Heavy Bupivacaine for spinal anesthesia
Routine clinical heavy bupivacaine doses
Normotensive group
Patients who are not hypotensive under spinal anesthesia with routine doses of heavy bupivacaine
Mini-mental 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
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
The 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
Heavy Bupivacaine for spinal anesthesia
Routine clinical heavy bupivacaine doses
Interventions
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Hypotension during spinal anesthesia for cesarean section
Hypotension, Mean Arterial Pressure\<65 mmHg, or Systolic arterial pressure \< 30% will be considered an initial value
Mini-mental 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
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
The 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
Heavy Bupivacaine for spinal anesthesia
Routine clinical heavy bupivacaine doses
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Principal Investigators
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esra uyar türkyılmaz
Role: PRINCIPAL_INVESTIGATOR
Ankara Bilkent City Hospital Ankara Turkey
Locations
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Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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E2-23-3719
Identifier Type: -
Identifier Source: org_study_id
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