Cerebral and Renal Oxymetry and Anesthetic Techniques in Newborns

Antalya Training and Research Hospital

Status: Completed

Conditions: Cesarean Delivery Affecting Newborn

Treatments: Device: Near infrared spectroscopy (spinal anesthesia); Device: Near infrared spectroscopy (general anesthesia)

Study type: Interventional

Funder types: Other

Identifiers

NCT03389139

AntalyaTRH 18

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

spinal anesthesia

Active Comparator group

Description:

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

Treatment:

Device: Near infrared spectroscopy (spinal anesthesia)

general anesthesia

Active Comparator group

Description:

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

Treatment:

Device: Near infrared spectroscopy (general anesthesia)