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

NCT05843838 | Recruiting

• 1 other identifier: E2-23-3719
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

cesarean section; postoperative cognitive dysfunction; hypotension

Outcome Measures

Primary Outcomes (1)

• 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.

  Preoperative (in 10 minutes before operation) to postoperative first hour.

Study Arms (2)

Hypotensive group

EXPERIMENTAL

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.)

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

Normotensive group

PLACEBO COMPARATOR

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

Diagnostic Test: Mini-mental test; Procedure: Spinal anesthesia; Diagnostic Test: The Bromage scale; Drug: Heavy Bupivacaine for spinal anesthesia

Interventions

Hypotension during spinal anesthesia for cesarean section PROCEDURE

Hypotension, Mean Arterial Pressure\<65 mmHg, or Systolic arterial pressure \< 30% will be considered an initial value

Hypotensive group

Mini-mental test DIAGNOSTIC_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.

Hypotensive group; Normotensive group

Spinal anesthesia PROCEDURE

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.

Hypotensive group; Normotensive group

The Bromage scale DIAGNOSTIC_TEST

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

Hypotensive group; Normotensive group

Heavy Bupivacaine for spinal anesthesia DRUG

Routine clinical heavy bupivacaine doses

Hypotensive group; Normotensive group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications; Hypotension

Interventions

Cesarean Section; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• esra uyar türkyılmaz

  Ankara Bilkent City Hospital Ankara Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

nihan aydın güzey

CONTACT

+90 505 6496231; nihanaydinguzey@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: February 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

TU (1)