- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03044366
General Anesthesia Management in 15 Preterm Infant
February 7, 2017 updated by: Ahmet Selim Ozkan, Inonu University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Malatya, Turkey, 44090
- Inonu University Medical Faculty
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patiens who were operated about retinopathy of premature.
Description
Inclusion Criteria:
- all preterm infants who was decided to apply ROP
Exclusion Criteria:
- No patient was excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Characteristics of Anesthesia management
Evaluate the average value of these data.
|
general anesthesia management of preterm infants
|
|
Comorbidities
Evaluate the average value of these data.
|
general anesthesia management of preterm infants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the management of airway
Time Frame: up to 2 years
|
the management of airway
|
up to 2 years
|
|
gestational age
Time Frame: up to 2 years
|
gestational age
|
up to 2 years
|
|
American Society of Anesthesiologists physical status scores
Time Frame: up to 2 years
|
American Society of Anesthesiologists physical status scores
|
up to 2 years
|
|
post-conceptual age
Time Frame: up to 2 years
|
post-conceptual age
|
up to 2 years
|
|
weight at birth and surgery
Time Frame: up to 2 years
|
weight at birth and surgery
|
up to 2 years
|
|
duration of anesthesia and surgery
Time Frame: up to 2 years
|
duration of anesthesia and surgery
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
December 1, 2016
First Submitted That Met QC Criteria
February 2, 2017
First Posted (Estimate)
February 7, 2017
Study Record Updates
Last Update Posted (Estimate)
February 9, 2017
Last Update Submitted That Met QC Criteria
February 7, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASOZKAN-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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