search
Back to results

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

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hypotension during spinal anesthesia for cesarean section
Mini-mental test
Spinal anesthesia
The Bromage scale
Heavy Bupivacaine for spinal anesthesia
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Cognitive Dysfunction focused on measuring cesarean section, postoperative cognitive dysfunction, hypotension

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ankara Bilkent City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hypotensive group

Normotensive group

Arm Description

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.)

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

Outcomes

Primary Outcome Measures

Change in postoperative cognitive function related with hypotension in cesarean section
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.

Secondary Outcome Measures

Full Information

First Posted
April 13, 2023
Last Updated
September 5, 2023
Sponsor
Ankara City Hospital Bilkent
search

1. Study Identification

Unique Protocol Identification Number
NCT05843838
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
cesarean section, postoperative cognitive dysfunction, hypotension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypotensive group
Arm Type
Experimental
Arm Description
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.)
Arm Title
Normotensive group
Arm Type
Placebo Comparator
Arm Description
Patients who are not hypotensive under spinal anesthesia with routine doses of heavy bupivacaine
Intervention Type
Procedure
Intervention Name(s)
Hypotension during spinal anesthesia for cesarean section
Intervention Description
Hypotension, Mean Arterial Pressure<65 mmHg, or Systolic arterial pressure < 30% will be considered an initial value
Intervention Type
Diagnostic Test
Intervention Name(s)
Mini-mental test
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
The Bromage scale
Intervention Description
The Bromage scale is the accepted tool for motor block examination. The classification of these scores complete block: unable to move feet or knees almost complete: able to move feet only partial: just able to flex knees; free movement of feet no block: full movement of knees and feet
Intervention Type
Drug
Intervention Name(s)
Heavy Bupivacaine for spinal anesthesia
Intervention Description
Routine clinical heavy bupivacaine doses
Primary Outcome Measure Information:
Title
Change in postoperative cognitive function related with hypotension in cesarean section
Description
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.
Time Frame
Preoperative (in 10 minutes before operation) to postoperative first hour.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nihan aydın güzey
Phone
+90 505 6496231
Email
nihanaydinguzey@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
esra uyar türkyılmaz
Organizational Affiliation
Ankara Bilkent City Hospital Ankara Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Bilkent City Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
nihan aydın güzey
Phone
05056496231
Email
nihanaydinguzey@gmail.com
First Name & Middle Initial & Last Name & Degree
Esra Uyar Türkyılmaz
First Name & Middle Initial & Last Name & Degree
nihan aydın güzey
First Name & Middle Initial & Last Name & Degree
Namık Özcan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs