Brain Oxygenation in Newborns Due to Neuroaksial Methods

NCT06316596 | Not Yet Recruiting DMC

• 1 other identifier: 2011-KAEK-25 2023/09-16
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Epidural and spinal anesthesia techniques are frequently used all over the world in elective cesarean section operations. To evaluate the effects of epidural and spinal anesthesia techniques applied in cesarean section surgery on neonatal cerebral oxygenation using Near Infrared Spectroscopy (NIRS).

Conditions

Cesarean Section; Pregnancy Related; Cerebral Hypoxia; Anesthesia, Regional; Oxygen Saturation

Keywords

Anesthesia, Spinal; Anesthesia, Epidural; Newborn; Oxygen; Hypotension

Outcome Measures

Primary Outcomes (1)

• Near İnfrared Spectroscopi

  Near Infrared Spectroscopy (NIRS,infant,saturation sensor, Invos , Tullamore, Ireland) monitors hemodynamic activity in the brain, offering the potential for cerebral monitoring in the region of interest.NIRS is a probe-guided device used for brain oxygenation in newborns.

  on 10 minutes

Secondary Outcomes (3)

• Maternal mean arterial pressure

  during cesarean section

• Newborn vitalty

  10 minutes after birth

• Newborn vitalty

  10 minutes after birth

Study Arms (2)

NEWBORN BORN AFTER EPIDURAL ANESTHESIA

ACTIVE COMPARATOR

Group epidural, 0.5% buvasin® will be applied epidural space in the lateral position after monitoring. The patient will be placed in the supine position and surgery will begin when the T5 spinal level is achieved. Pregnant heart rate, blood pressure and saturation values will be recorded at intervals and iv ephedrine will be administered when there is a 25% or more drop in blood pressure. When there is a 25% or more decrease in heart rate, iv atropine will be administered. A NIRS probe (infant,saturation sensor, Invos , Tullamore, Ireland) and pulse will be attached to the newborn by another anesthetist and the measurements will be recorded. Blood pressure will be taken from the umbilical vein. APGAR(activity,pulse,grimace,appearance,respiration), heart rate, SpO2 and umbilical vein saturation values of the newborn will be recorded. NIRS and spO2 values of the newborn will be checked intermittently.

Procedure: Epidural Anesthesia

NEWBORN BORN AFTER SPINAL ANESTHESIA

ACTIVE COMPARATOR

Group spinal, 0.5% buvasin® heavy will be applied spinal space in the lateral position after monitoring. Surgery will begin when the patient is placed in the supine position and T5 spinal level is achieved. Pregnant heart rate, blood pressure, and saturation values are recorded at regular intervals, and when there is a 25% or more drop in blood pressure, the patient will be given iv ephedrine. When there is a 25% or more drop in heart rate, iv atropine will be administered. A NIRS probe (infant,saturation sensor, Invos , Tullamore, Ireland) and pulse will be attached to the newborn by another anesthetist and the measurements will be recorded. Blood pressure will be taken from the umbilical vein. The newborn's APGAR(activity,pulse,grimace,appearance,respiration), heart rate, SpO2 and umbilical venous saturation values will be recorded. NIRS and spO2 values will be checked intermittently.

Procedure: Spinal Anesthesia

Interventions

Spinal Anesthesia PROCEDURE

Near infrared spectroscopy , neonatal peripheral oxygen saturation measurements and hemodynamic data will be compared between groups

NEWBORN BORN AFTER SPINAL ANESTHESIA

Epidural Anesthesia PROCEDURE

Near infrared spectroscopy , neonatal peripheral oxygen saturation measurements and hemodynamic data will be compared between groups

NEWBORN BORN AFTER EPIDURAL ANESTHESIA

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women between the ages of 18-35 and newborns after cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between the ages of 18-35 and newborns after cesarean section
• Newborns born \>37 weeks of gestation
• ASA II pregnant women

You may not qualify if:

• Previous local anesthetic allergy
• Those with bleeding diathesis disorder
• Having a mental disorder
• Those who are allergic to the drugs used
• Patients who did not consent to participate in the study
• Height \<1.55 meters. or \>1.70 meters.
• Presence of infection in the block area
• Body mass index \>35 kg/m²
• Those with gestational hypertension and SAP\>140 mmHg or DAP\>90 mmHg in three pre-pregnancy measurements
• Known presence of fetal anomaly
• Those with known placenta pathology
• Those with a history of fetal anomaly and abnormal birth in previous pregnancies

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

MeSH Terms

Conditions

Hypoxia, Brain; Hypotension

Interventions

Anesthesia, Spinal; Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ahsen Gür Çelik

  gurahsen@gmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahsen Gür Çelik

CONTACT

+905071213621; gurahsen@gmail.com

Derya Karasu

CONTACT

+905057281175; drderyatopuz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The research is a prospective, randomized, single-blind, parallel group study. In the study, the Quincke needle will be used for spinal anesthesia and the Tuoghy needle will be used for epidural anesthesia. Oxygenation will be evaluated with the help of NIRS probe in the post-cesarean newborns of pregnant women who will undergo elective cesarean section. Vitals will be monitored throughout the case with electrocardiography (ECG), non-invasive blood pressure monitoring and spO2. The amount of vasopressor agent and hydration required by the mother throughout the case will be recorded. While one anesthesiologist will monitor the anesthesia method and maternal vitals, the other anesthetist will monitor the NIRS monitoring attached to the newborn.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of anesthesiology and reanimation

Model Details: The research is a prospective controlled,randomized,double-blind study

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: March 18, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share