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
1 other identifier
interventional
60
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 19, 2017
CompletedFirst Posted
Study publicly available on registry
January 3, 2018
CompletedJuly 20, 2023
July 1, 2023
5 months
December 19, 2017
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
preductal SpO2
60 minutes after birth
postductal SpO2
60 minutes after birth
perfusion index
60 minutes after birth
body temperature
60 minutes after birth
apgar scores
1st and 5th minute after birth
Study Arms (2)
spinal anesthesia
ACTIVE COMPARATORPatients in this group were randomized to receive spinal anesthesia. (Near infrared spectroscopy (spinal anesthesia))
general anesthesia
ACTIVE COMPARATORPatients in this group were randomized to receive general anesthesia. (Near infrared spectroscopy (general anesthesia)).
Interventions
effect of spinal anesthesia on regional renal and cerebral oxygen saturation in newborns
effect of general anesthesia on regional renal and cerebral oxygen saturation in newborns
Eligibility Criteria
You may qualify if:
- patients who undergo elective cesarean
- American Society of Anesthesiologists class 1 to 2
- Ability to consent
- Gestational age: from 37 to 41 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2017
First Posted
January 3, 2018
Study Start
January 1, 2017
Primary Completion
June 1, 2017
Study Completion
August 1, 2017
Last Updated
July 20, 2023
Record last verified: 2023-07