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

Not Applicable

Recruiting

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: 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

• Registration Number: NCT05843838
• Lead Sponsor: Ankara City Hospital Bilkent

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

Study Timeline

• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-06
• Status Verified: 2024-02
• Study Start: 2024-02-01
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2024-04-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypotensive group	Hypotension during spinal anesthesia for cesarean section	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.)
Hypotensive group	Mini-mental test	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.)
Hypotensive group	Spinal anesthesia	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.)
Hypotensive group	The Bromage scale	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.)
Hypotensive group	Heavy Bupivacaine for spinal anesthesia	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	Mini-mental test	Patients who are not hypotensive under spinal anesthesia with routine doses of heavy bupivacaine
Normotensive group	Spinal anesthesia	Patients who are not hypotensive under spinal anesthesia with routine doses of heavy bupivacaine
Normotensive group	The Bromage scale	Patients who are not hypotensive under spinal anesthesia with routine doses of heavy bupivacaine
Normotensive group	Heavy Bupivacaine for spinal anesthesia	Patients who are not hypotensive under spinal anesthesia with routine doses of heavy bupivacaine

Primary Outcome Measures

Name	Time	Method
Change in postoperative cognitive function related with hypotension in cesarean section	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.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey