Clinical trial NCT05843838: The Effect of Intraoperative Hypotension on Postoperative Cognitive Functions in Cesarean Section Operations
Official title: The Effect of Intraoperative Hypotension on Postoperative Cognitive Functions in Cesarean Section Operations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Keywords: cesarean section
postoperative cognitive dysfunction
hypotension
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in postoperative cognitive function related with hypotension in cesarean section
timeFrame: Preoperative (in 10 minutes before operation) to postoperative first hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara Bilkent City Hospital Ankara Turkey
name: esra uyar türkyılmaz
role: PRINCIPAL_INVESTIGATOR
References: