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

Sponsor

Ankara City Hospital Bilkent (Other)

Overall Status

Recruiting

CT.gov ID

NCT05843838

Collaborator

(none)

150

Enrollment

Location

Arms

2.6

Anticipated Duration (Months)

57.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Cognitive Dysfunction	Procedure: Hypotension during spinal anesthesia for cesarean section Diagnostic Test: Mini-mental test	N/A

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<65 mmHg, or SAP < 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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 27, 2023

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Jun 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypotensive group Patients who are hypotensive (even once) and need ephedrine under spinal anesthesia with routine doses of heavy marcaine (Hypotension, Mean Arterial Pressure<65 mmHg, or Systolic arterial pressure < 30% will be considered an initial value.)	Procedure: Hypotension during spinal anesthesia for cesarean section All patients will be given a mini mental test at preop and post op 1st hour. 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. 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.
Placebo Comparator: Normotensive group Patients who are not hypotensive under spinal anesthesia with routine doses of heavy marcaine	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.

Arm

Intervention/Treatment

Experimental: Hypotensive group

Patients who are hypotensive (even once) and need ephedrine under spinal anesthesia with routine doses of heavy marcaine (Hypotension, Mean Arterial Pressure<65 mmHg, or Systolic arterial pressure < 30% will be considered an initial value.)

Procedure: Hypotension during spinal anesthesia for cesarean section

All patients will be given a mini mental test at preop and post op 1st hour. 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.

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.

Placebo Comparator: Normotensive group

Patients who are not hypotensive under spinal anesthesia with routine doses of heavy marcaine

Diagnostic Test: Mini-mental test

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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