NCT05843838

The Effect of Intraoperative Hypotension on Postoperative Cognitive Functions in Cesarean Section Operations

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Conditions

• Postoperative Cognitive Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Hypotension during spinal anesthesia for cesarean section	Hypotension, Mean Arterial Pressure\<65 mmHg, or Systolic arterial pressure \< 30% will be considered an initial value
DIAGNOSTIC_TEST	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.
PROCEDURE	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.
DIAGNOSTIC_TEST	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
DRUG	Heavy Bupivacaine for spinal anesthesia	Routine clinical heavy bupivacaine doses

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-04-01
• Completion: 2024-05-01
• First posted: 2023-05-06
• Last updated: 2024-02-08

Locations

1 site across 1 country: Turkey (Türkiye)