Skip to main content
OpenTrials
Completed

NCT Number: NCT03389139

Cerebral and Renal Oxymetry and Anesthetic Techniques in Newborns

Neonatal adaptation to extrauterine life has many physiological changes in neonatal organ systems. These adaptative changes may be affected such as type of delivery and anesthesia management at birth. near infrared spectroscopy (NIRS) is a popular non-invasive method that can be used in newborns thus monitorize tissue oxygenation regularly. In this study we have purposed to compare the effects of general anesthesia versus spinal anesthesia on newborn's cerebral and renal oxygenation in elective cesarean operations

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Delivery Affecting Newborn

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The cases divided into two groups those spinal anesthesia group ( group:1; n:30 ) and general anesthesia group (group:2; n:30). The preoperative and intraoperative mean arterial pressures (MAP), heart rate (HR), arterial oxyhemoglobin saturation (SpO2), intraoperative blood loss values of pregnants and 1st-5th minute APGAR scores, preductal and postductal SpO2, perfusion index, heart rates, body temperature, cerebral and renal regional oxygen saturations of newborns after birth have been recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who undergo elective cesarean
  • American Society of Anesthesiologists class 1 to 2
  • Ability to consent
  • Gestational age: from 37 to 41 weeks

Exclusion criteria

  • Pulmonary disease
  • History of allergic reaction to local anaesthetics
  • Peripheral neuropathy
  • Neurologic disease
  • Coagulation disorders
  • newborns with anomalies
  • low birth weight newborns
  • newborns needing neonatal resuscitation

Treatment and study plan

Near infrared spectroscopy (spinal anesthesia)

Device

effect of spinal anesthesia on regional renal and cerebral oxygen saturation in newborns

Near infrared spectroscopy (general anesthesia)

Device

effect of general anesthesia on regional renal and cerebral oxygen saturation in newborns

Primary outcomes

  1. Change in renal and cerebral regional oxygenation (rSO2) in newborn

    Time frame: 60 minutes after birth

    Assessed at third and fifth minutes and then every 5 minutes after birth

Secondary outcomes

  1. preductal SpO2

    Time frame: 60 minutes after birth

    changes in preductal SpO2 after birth

  2. postductal SpO2

    Time frame: 60 minutes after birth

    changes in postductal SpO2 after birth

  3. perfusion index

    Time frame: 60 minutes after birth

    changes in perfusion index after birth

  4. body temperature

    Time frame: 60 minutes after birth

    changes in body temperature after birth

  5. apgar scores

    Time frame: 1st and 5th minute after birth

    changes in apgar scores after birth

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of the Effects of Anesthetic Techniques Used for Cesarean Delivery on Neonatal Cerebral and Renal Oxygenation

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 3, 2018
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.