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General Anesthesia Management in 15 Preterm Infant

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ClinicalTrials.gov Identifier: NCT03044366
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmet Selim Ozkan, Inonu University

Brief 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. This retrospective study evaluates the perioperative management and postoperative course in premature infants undergoing diode laser photocoagulation (DLP) for retinopathy of prematurity (ROP).

Condition or disease Intervention/treatment
Anesthesia Management of Premature Infants Other: general anesthesia management of preterm infants

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(%).

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: General Anesthesia Management in 15 Preterm Infant Undergoing Diode Laser Photocoagulation for Retinopathy of Prematurity: A Retrospective Study
Study Start Date : December 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Characteristics of Anesthesia management
Evaluate the average value of these data.
Other: general anesthesia management of preterm infants
general anesthesia management of preterm infants

Comorbidities
Evaluate the average value of these data.
Other: general anesthesia management of preterm infants
general anesthesia management of preterm infants




Primary Outcome Measures :
  1. the management of airway [ Time Frame: up to 2 years ]
    the management of airway

  2. gestational age [ Time Frame: up to 2 years ]
    gestational age

  3. American Society of Anesthesiologists physical status scores [ Time Frame: up to 2 years ]
    American Society of Anesthesiologists physical status scores

  4. post-conceptual age [ Time Frame: up to 2 years ]
    post-conceptual age

  5. weight at birth and surgery [ Time Frame: up to 2 years ]
    weight at birth and surgery

  6. duration of anesthesia and surgery [ Time Frame: up to 2 years ]
    duration of anesthesia and surgery



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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patiens who were operated about retinopathy of premature.
Criteria

Inclusion Criteria:

  • all preterm infants who was decided to apply ROP

Exclusion Criteria:

  • No patient was excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044366


Locations
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Turkey
Inonu University Medical Faculty
Malatya, Turkey, 44090
Sponsors and Collaborators
Inonu University

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Responsible Party: Ahmet Selim Ozkan, M.D., Inonu University
ClinicalTrials.gov Identifier: NCT03044366     History of Changes
Other Study ID Numbers: ASOZKAN-1
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Retinopathy of Prematurity
Retinal Diseases
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs