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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Delivery Affecting Newborn
• Intervention / Treatment: Device: Near infrared spectroscopy (spinal anesthesia); Device: Near infrared spectroscopy (general anesthesia)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: spinal anesthesia; Patients in this group were randomized to receive spinal anesthesia. (Near infrared spectroscopy (spinal anesthesia))	Device: Near infrared spectroscopy (spinal anesthesia); effect of spinal anesthesia on regional renal and cerebral oxygen saturation in newborns
Active Comparator: general anesthesia; Patients in this group were randomized to receive general anesthesia. (Near infrared spectroscopy (general anesthesia)).	Device: Near infrared spectroscopy (general anesthesia); effect of general anesthesia on regional renal and cerebral oxygen saturation in newborns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in renal and cerebral regional oxygenation (rSO2) in newborn	Assessed at third and fifth minutes and then every 5 minutes after birth	60 minutes after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preductal SpO2	changes in preductal SpO2 after birth	60 minutes after birth
postductal SpO2	changes in postductal SpO2 after birth	60 minutes after birth
perfusion index	changes in perfusion index after birth	60 minutes after birth
body temperature	changes in body temperature after birth	60 minutes after birth
apgar scores	changes in apgar scores after birth	1st and 5th minute after birth

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Study Director: Ulku Arslan, MD, Antalya Training and Research Hospital; Principal Investigator: Nilgun Kavrut Ozturk, MD, Antalya Training and Research Hospital; Principal Investigator: Ali Sait Kavakli, MD, Antalya Training and Research Hospital; Principal Investigator: Ozge Dagdelen, MD, Antalya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 26, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: anesthesia; Cesarean; newborn; cerebral and renal oxygenation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: AntalyaTRH 18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No