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Clinical Trials/NCT03389139
NCT03389139
Completed
N/A

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

Antalya Training and Research Hospital0 sites60 target enrollmentJanuary 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cesarean Delivery Affecting Newborn
Sponsor
Antalya Training and Research Hospital
Enrollment
60
Primary Endpoint
Change in renal and cerebral regional oxygenation (rSO2) in newborn
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
August 2017
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Antalya Training and Research Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in renal and cerebral regional oxygenation (rSO2) in newborn

Time Frame: 60 minutes after birth

Assessed at third and fifth minutes and then every 5 minutes after birth

Secondary Outcomes

  • body temperature(60 minutes after birth)
  • perfusion index(60 minutes after birth)
  • preductal SpO2(60 minutes after birth)
  • postductal SpO2(60 minutes after birth)
  • apgar scores(1st and 5th minute after birth)

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