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Cerebral and Renal Oxymetry and Anesthetic Techniques in Newborns

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03389139
Enrollment
60
Registered
2018-01-03
Start date
2017-01-31
Completion date
2017-08-31
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery Affecting Newborn

Keywords

Cesarean, newborn, cerebral and renal oxygenation, anesthesia

Brief summary

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

Detailed description

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.

Interventions

DEVICENear infrared spectroscopy (spinal anesthesia)

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

DEVICENear infrared spectroscopy (general anesthesia)

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

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in renal and cerebral regional oxygenation (rSO2) in newborn60 minutes after birthAssessed at third and fifth minutes and then every 5 minutes after birth

Secondary

MeasureTime frameDescription
preductal SpO260 minutes after birthchanges in preductal SpO2 after birth
postductal SpO260 minutes after birthchanges in postductal SpO2 after birth
perfusion index60 minutes after birthchanges in perfusion index after birth
body temperature60 minutes after birthchanges in body temperature after birth
apgar scores1st and 5th minute after birthchanges in apgar scores after birth

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026