Cesarean Delivery Affecting NewbornNCT03389139
Cerebral and Renal Oxymetry and Anesthetic Techniques in Newborns
A study testing Near infrared spectroscopy (spinal anesthesia) and Near infrared spectroscopy (general anesthesia) in people with Cesarean Delivery Affecting Newborn, run by Antalya Training and Research Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cesarean Delivery Affecting Newborn
- What is being tested?
- Near infrared spectroscopy (spinal anesthesia) and Near infrared spectroscopy (general anesthesia)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients who undergo elective cesarean
- American Society of Anesthesiologists class 1 to 2
- Ability to consent
- Gestational age: from 37 to 41 weeks
Who cannot join
- 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
About this study
Official title: 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
Read the 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.
- Conditions
- Cesarean Delivery Affecting Newborn
- Being tested
- Near infrared spectroscopy (spinal anesthesia), Near infrared spectroscopy (general anesthesia)
- Keywords
- Cesarean, newborn, cerebral and renal oxygenation, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopy (spinal anesthesia)Device
effect of spinal anesthesia on regional renal and cerebral oxygen saturation in newborns
Near infrared spectroscopy (general anesthesia)Device
effect of general anesthesia on regional renal and cerebral oxygen saturation in newborns
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia | Active comparator | Patients in this group were randomized to receive spinal anesthesia. (Near infrared spectroscopy (spinal anesthesia)) Receives: Device: Near infrared spectroscopy (spinal anesthesia) |
| general anesthesia | Active comparator | Patients in this group were randomized to receive general anesthesia. (Near infrared spectroscopy (general anesthesia)). Receives: Device: Near infrared spectroscopy (general anesthesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in renal and cerebral regional oxygenation (rSO2) in newborn
Assessed at third and fifth minutes and then every 5 minutes after birth
Measured: 60 minutes after birth
Secondary outcomes (5)
preductal SpO2
changes in preductal SpO2 after birth
Measured: 60 minutes after birth
postductal SpO2
changes in postductal SpO2 after birth
Measured: 60 minutes after birth
perfusion index
changes in perfusion index after birth
Measured: 60 minutes after birth
body temperature
changes in body temperature after birth
Measured: 60 minutes after birth
apgar scores
changes in apgar scores after birth
Measured: 1st and 5th minute after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study startJan 2017
- Primary completionJun 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Delivery Affecting NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ulku Arslan, MD, Study director, Antalya Training and Research HospitalNilgun Kavrut Ozturk, MD, Principal investigator, Antalya Training and Research HospitalAli Sait Kavakli, MD, Principal investigator, Antalya Training and Research HospitalOzge Dagdelen, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389139
- Sponsor's protocol ID
- AntalyaTRH 18
- Status last verified
- Jul 2023
- First submitted
- 19 Dec 2017
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Anesthetic Techniques Used for Cesarean Delivery on Neonatal Cerebral and Renal Oxygenation
- ClinicalTrials.gov ID
- NCT03389139
- Acronym / sponsor ID
- AntalyaTRH 18
- Conditions
- Cesarean Delivery Affecting Newborn
- Keywords
- Cesarean, newborn, cerebral and renal oxygenation, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia | Active comparator | Device: Near infrared spectroscopy (spinal anesthesia)Patients in this group were randomized to receive spinal anesthesia. (Near infrared spectroscopy (spinal anesthesia)) |
| general anesthesia | Active comparator | Device: Near infrared spectroscopy (general anesthesia)Patients in this group were randomized to receive general anesthesia. (Near infrared spectroscopy (general anesthesia)). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients who undergo elective cesarean
- American Society of Anesthesiologists class 1 to 2
- Ability to consent
- Gestational age: from 37 to 41 weeks
Key exclusion criteria (8 listed)
- Pulmonary disease
- History of allergic reaction to local anaesthetics
- Peripheral neuropathy
- Neurologic disease
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near infrared spectroscopy (spinal anesthesia)effect of spinal anesthesia on regional renal and cerebral oxygen saturation in newborns | Device | spinal anesthesia |
| Near infrared spectroscopy (general anesthesia)effect of general anesthesia on regional renal and cerebral oxygen saturation in newborns | Device | general anesthesia |
Primary outcome
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
5 secondary outcomes
preductal SpO2
Time frame: 60 minutes after birth
postductal SpO2
Time frame: 60 minutes after birth
perfusion index
Time frame: 60 minutes after birth
body temperature
Time frame: 60 minutes after birth
apgar scores
Time frame: 1st and 5th minute after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulku Arslan, MD study director
Antalya Training and Research Hospital
Nilgun Kavrut Ozturk, MD principal investigator
Antalya Training and Research Hospital
Ali Sait Kavakli, MD principal investigator
Antalya Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Near infrared spectroscopy (spinal anesthesia) and Near infrared spectroscopy (general anesthesia) in people with Cesarean Delivery Affecting Newborn, run by Antalya Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in renal and cerebral regional oxygenation (rSO2) in newborn (time frame: 60 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.