Cerebral and Renal Oxymetry and Anesthetic Techniques in Newborns

Cesarean Delivery Affecting Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389139
• Other study ID #: AntalyaTRH 18
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: August 2017

Study information

• Verified date: July 2023
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Delivery Affecting Newborn

Intervention

Device:
• Near infrared spectroscopy (spinal anesthesia)
effect of spinal anesthesia on regional renal and cerebral oxygen saturation in newborns
• Near infrared spectroscopy (general anesthesia)
effect of general anesthesia on regional renal and cerebral oxygen saturation in newborns

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	preductal SpO2	changes in preductal SpO2 after birth	60 minutes after birth
Secondary	postductal SpO2	changes in postductal SpO2 after birth	60 minutes after birth
Secondary	perfusion index	changes in perfusion index after birth	60 minutes after birth
Secondary	body temperature	changes in body temperature after birth	60 minutes after birth
Secondary	apgar scores	changes in apgar scores after birth	1st and 5th minute after birth