Anesthesia Management of Premature InfantsNCT03044366
General Anesthesia Management in 15 Preterm Infant
An observational study of Anesthesia Management of Premature Infants, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Anesthesia management of preterm infants is challenging for the anesthesiologist. Because of rudimentary build, many medical and physical problems have shown in treatment of disease such as complications, airway problems, temperature disregulation and deficient drug metabolism. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Anesthesia Management of Premature Infants
- What is being tested?
- general anesthesia management of preterm infants
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2016to Jan 2017
- Phase
- Observational
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: patiens who were operated about retinopathy of premature.
Who may be able to join
- all preterm infants who was decided to apply ROP
Who cannot join
- No patient was excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Medical Faculty
Malatya, Malatya, 44090
About this study
Official title: General Anesthesia Management in 15 Preterm Infant Undergoing Diode Laser Photocoagulation for Retinopathy of Prematurity: A Retrospective Study
Anesthesia management of preterm infants is challenging for the anesthesiologist. Because of rudimentary build, many medical and physical problems have shown in treatment of disease such as complications, airway problems, temperature disregulation and deficient drug metabolism. This retrospective study evaluates the perioperative management and postoperative course in premature infants undergoing diode laser photocoagulation (DLP) for retinopathy of prematurity (ROP).
Read the detailed description
Participants retrospectively investigate clinical data and anesthesia process of 15 preterm infant from anesthesia charts with ROP who underwent DLP between 2014 and 2016. This presented retrospective study was confirmed by the Institutional Clinical Research Ethics Board. Neonates burns under 30 weeks gestation and low birth weigh under 2000 g were admitted to the study. No infant were excluded from the study. Preterm infants were appreciated before surgery and informed consent was obtained form their parents. We recorded gestational age, American Society of Anesthesiologists (ASA) physical status scores, post-conceptual age, weight at birth and surgery, duration of anesthesia and surgery, blood glucose values at surgery, the management of airway, total hospital stay period, analgesia management, complications and comorbidities. Bradycardia ( <90 beats/mean), desaturation (SpO2 <90%) and arrhythmia were recorded. Electrocardiography (ECG), pulse oximetric saturation (SpO2), end-tidal carbon dioxide pressure, heart rate (HR) and body temperature were monitored in operating room. Topical 0.5% proparacaine eye drops were administered to all infants routinely. Anesthesia was induced with thiopental 6 mg kg-1 and fentanyl 1 µg kg-1 and it was maintained with 50% oxygen 50% air 1%-3% sevoflurane in all cases. Inhaled anesthetic agent was not preferred for induction of anesthesia because of causing hypotension. The premature infants were intubated by same experienced anesthesiologist. In all infants, were intubated the patients without muscle relaxant under spontaneous ventilation. Perioperative complications, blood glucose value, devices in airway management and extubation value were recorded. After surgery, extubation was performed when spontanea ventilation was enough and extubation was recorded. All infants were taken to newborn intensive care unit (NICU). Data are reported as mean ± standard deviation and percentage(%).
- Being tested
- general anesthesia management of preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesia management of preterm infantsOther
general anesthesia management of preterm infants
| Study group | Role | What they receive |
|---|---|---|
| Characteristics of Anesthesia management | Evaluate the average value of these data. Receives: Other: general anesthesia management of preterm infants | |
| Comorbidities | Evaluate the average value of these data. Receives: Other: general anesthesia management of preterm infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
the management of airway
the management of airway
Measured: up to 2 years
gestational age
gestational age
Measured: up to 2 years
American Society of Anesthesiologists physical status scores
American Society of Anesthesiologists physical status scores
Measured: up to 2 years
post-conceptual age
post-conceptual age
Measured: up to 2 years
weight at birth and surgery
weight at birth and surgery
Measured: up to 2 years
duration of anesthesia and surgery
duration of anesthesia and surgery
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startDec 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Management of Premature InfantsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Selim Ozkan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044366
- Sponsor's protocol ID
- ASOZKAN-1
- Status last verified
- Feb 2017
- First submitted
- 1 Dec 2016
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia Management in 15 Preterm Infant Undergoing Diode Laser Photocoagulation for Retinopathy of Prematurity: A Retrospective Study
- ClinicalTrials.gov ID
- NCT03044366
- Acronym / sponsor ID
- ASOZKAN-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Feb 2017 (estimated)
- 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.
Anesthesia management of preterm infants is challenging for the anesthesiologist. Because of rudimentary build, many medical and physical problems have shown in treatment of disease such as complications, airway problems, temperature disregulation and deficient drug metabolism. This retrospective study evaluates the perioperative management and postoperative course in premature infants undergoing diode laser photocoagulation (DLP) for retinopathy of prematurity (ROP).
Detailed description
Participants retrospectively investigate clinical data and anesthesia process of 15 preterm infant from anesthesia charts with ROP who underwent DLP between 2014 and 2016. This presented retrospective study was confirmed by the Institutional Clinical Research Ethics Board. Neonates burns under 30 weeks gestation and low birth weigh under 2000 g were admitted to the study. No infant were excluded from the study. Preterm infants were appreciated before surgery and informed consent was obtained form their parents. We recorded gestational age, American Society of Anesthesiologists (ASA) physical status scores, post-conceptual age, weight at birth and surgery, duration of anesthesia and surgery, blood glucose values at surgery, the management of airway, total hospital stay period, analgesia management, complications and comorbidities. Bradycardia ( <90 beats/mean), desaturation (SpO2 <90%) and arrhythmia were recorded. Electrocardiography (ECG), pulse oximetric saturation (SpO2), end-tidal carbon dioxide pressure, heart rate (HR) and body temperature were monitored in operating room. Topical 0.5% proparacaine eye drops were administered to all infants routinely. Anesthesia was induced with thiopental 6 mg kg-1 and fentanyl 1 µg kg-1 and it was maintained with 50% oxygen 50% air 1%-3% sevoflurane in all cases. Inhaled anesthetic agent was not preferred for induction of anesthesia because of causing hypotension. The premature infants were intubated by same experienced anesthesiologist. In all infants, were intubated the patients without muscle relaxant under spontaneous ventilation. Perioperative complications, blood glucose value, devices in airway management and extubation value were recorded. After surgery, extubation was performed when spontanea ventilation was enough and extubation was recorded. All infants were taken to newborn intensive care unit (NICU). Data are reported as mean ± standard deviation and percentage(%).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Characteristics of Anesthesia management | – | Other: general anesthesia management of preterm infantsEvaluate the average value of these data. |
| Comorbidities | – | Other: general anesthesia management of preterm infantsEvaluate the average value of these data. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patiens who were operated about retinopathy of premature.
Key inclusion criteria (1 listed)
- all preterm infants who was decided to apply ROP
Key exclusion criteria (1 listed)
- No patient was excluded
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 |
|---|---|---|
| general anesthesia management of preterm infantsgeneral anesthesia management of preterm infants | Other | Characteristics of Anesthesia management, Comorbidities |
Primary outcome
the management of airway
Time frame: up to 2 years
the management of airway
gestational age
Time frame: up to 2 years
gestational age
American Society of Anesthesiologists physical status scores
Time frame: up to 2 years
American Society of Anesthesiologists physical status scores
post-conceptual age
Time frame: up to 2 years
post-conceptual age
weight at birth and surgery
Time frame: up to 2 years
weight at birth and surgery
duration of anesthesia and surgery
Time frame: up to 2 years
duration of anesthesia and surgery
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 9 Feb 2017.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Management of Premature Infants, run by Inonu University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
the management of airway (time frame: up to 2 years). The study lists 6 primary outcomes in all. 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 9 Feb 2017.