Cerebral and Renal Oxymetry and Anesthetic Techniques in Newborns

Not Applicable

Completed

• Conditions: Cesarean Delivery Affecting Newborn
• Interventions: Device: Near infrared spectroscopy (general anesthesia); Device: Near infrared spectroscopy (spinal anesthesia)

• Registration Number: NCT03389139
• Lead Sponsor: Antalya Training and Research Hospital

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.

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2017-06
• Study Completion: 2017-08
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-26
• Study First Posted: 2018-01-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general anesthesia	Near infrared spectroscopy (general anesthesia)	Patients in this group were randomized to receive general anesthesia. (Near infrared spectroscopy (general anesthesia)).
spinal anesthesia	Near infrared spectroscopy (spinal anesthesia)	Patients in this group were randomized to receive spinal anesthesia. (Near infrared spectroscopy (spinal anesthesia))

Primary Outcome Measures

Name	Time	Method
Change in renal and cerebral regional oxygenation (rSO2) in newborn	60 minutes after birth	Assessed at third and fifth minutes and then every 5 minutes after birth

Secondary Outcome Measures

Name	Time	Method
body temperature	60 minutes after birth	changes in body temperature after birth
preductal SpO2	60 minutes after birth	changes in preductal SpO2 after birth
postductal SpO2	60 minutes after birth	changes in postductal SpO2 after birth
perfusion index	60 minutes after birth	changes in perfusion index after birth
apgar scores	1st and 5th minute after birth	changes in apgar scores after birth