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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03044366
Other study ID # ASOZKAN-1
Secondary ID
Status Completed
Phase N/A
First received December 1, 2016
Last updated February 7, 2017
Start date December 2016
Est. completion date January 2017

Study information

Verified date February 2017
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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


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(%).


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Month
Eligibility Inclusion Criteria:

- all preterm infants who was decided to apply ROP

Exclusion Criteria:

- No patient was excluded

Study Design


Related Conditions & MeSH terms


Intervention

Other:
general anesthesia management of preterm infants
general anesthesia management of preterm infants

Locations

Country Name City State
Turkey Inonu University Medical Faculty Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary the management of airway the management of airway up to 2 years
Primary gestational age gestational age up to 2 years
Primary American Society of Anesthesiologists physical status scores American Society of Anesthesiologists physical status scores up to 2 years
Primary post-conceptual age post-conceptual age up to 2 years
Primary weight at birth and surgery weight at birth and surgery up to 2 years
Primary duration of anesthesia and surgery duration of anesthesia and surgery up to 2 years