search
Back to results

Anesthesia for Retinopathy of Prematurity

Primary Purpose

Retinopathy

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketamine
Sevoflurane
propofol
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinopathy focused on measuring Prematurity, Retinopathy, propofol, ketamine, sedation

Eligibility Criteria

32 Weeks - 40 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of ROP

Exclusion Criteria:

  • The exclusion criteria were patients requiring inotropic support,
  • the need for mechanical ventilation or intubation in the 3 days prior to the operation,
  • known allergy or hypersensitivity reaction to ketamine and propofol,
  • age ˃40 weeks.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    sedation

    general anesthesia

    Arm Description

    The sedation group (Group S, n=30), received 1 mg/kg ketamine and 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol and 0.25mg/kg/h of ketamine for maintenance.

    In the general anesthesia group (Group G, n=30), anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; endotracheal intubation was facilitated without use of a neuromuscular blocker agent. Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen.

    Outcomes

    Primary Outcome Measures

    Respiratory failure after retinopathy of prematurity surgery in premature infants.
    Most of premature infants have chronic lung disease, for this reason endotracheal intubation causes some problems, because they have irritable airway. Administration of sedation and avoiding endotracheal intubation can be better for postsurgical outcomes. How many infants needed endotracheal intubation and mechanical ventilation were recorded.

    Secondary Outcome Measures

    Blood Pressure
    non invasive blood pressure measured
    Heart rate
    heart rate per minute were recorded

    Full Information

    First Posted
    September 4, 2013
    Last Updated
    September 27, 2013
    Sponsor
    TC Erciyes University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01955135
    Brief Title
    Anesthesia for Retinopathy of Prematurity
    Official Title
    DECREASING THE NEED FOR MECHANICAL VENTILATION AFTER RETINOPATHY OF PREMATURITY SURGERY: Sedation vs General Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TC Erciyes University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Premature infants experience more respiratory problems after surgical procedures. The investigators aimed to compare general anesthesia with sedation on the need for post-operative mechanical ventilation in infants undergoing retinopathy of prematurity surgery.
    Detailed Description
    60 patients who underwent laser surgery due to retinopathy of prematurity (ROP) were included in the study. The sedation group (Group S, n=30), received 1 mg/kg ketamine and 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol and 0.25mg/kg/h of ketamine for maintenance. In the general anesthesia group (Group G, n=30), anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; endotracheal intubation was facilitated without use of a neuromuscular blocker agent. Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen. Our primary objective was to evaluate the need for post-operative mechanical ventilation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinopathy
    Keywords
    Prematurity, Retinopathy, propofol, ketamine, sedation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sedation
    Arm Type
    Active Comparator
    Arm Description
    The sedation group (Group S, n=30), received 1 mg/kg ketamine and 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol and 0.25mg/kg/h of ketamine for maintenance.
    Arm Title
    general anesthesia
    Arm Type
    Active Comparator
    Arm Description
    In the general anesthesia group (Group G, n=30), anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; endotracheal intubation was facilitated without use of a neuromuscular blocker agent. Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    ketalar, 50mg/ml
    Intervention Description
    1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Other Intervention Name(s)
    sevorein
    Intervention Description
    anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen
    Intervention Type
    Drug
    Intervention Name(s)
    propofol
    Other Intervention Name(s)
    pofol
    Intervention Description
    1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol
    Primary Outcome Measure Information:
    Title
    Respiratory failure after retinopathy of prematurity surgery in premature infants.
    Description
    Most of premature infants have chronic lung disease, for this reason endotracheal intubation causes some problems, because they have irritable airway. Administration of sedation and avoiding endotracheal intubation can be better for postsurgical outcomes. How many infants needed endotracheal intubation and mechanical ventilation were recorded.
    Time Frame
    1 Day (From end of anaesthesia till discharge from the recovery room )
    Secondary Outcome Measure Information:
    Title
    Blood Pressure
    Description
    non invasive blood pressure measured
    Time Frame
    1 Day (From start of anaesthesia till discharge from the operation room)
    Title
    Heart rate
    Description
    heart rate per minute were recorded
    Time Frame
    1 Day (From start of anaesthesia till discharge from the recovery room )

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    32 Weeks
    Maximum Age & Unit of Time
    40 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of ROP Exclusion Criteria: The exclusion criteria were patients requiring inotropic support, the need for mechanical ventilation or intubation in the 3 days prior to the operation, known allergy or hypersensitivity reaction to ketamine and propofol, age ˃40 weeks.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    AYŞE ÜLGEY, MD
    Organizational Affiliation
    TC Erciyes University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Anesthesia for Retinopathy of Prematurity

    We'll reach out to this number within 24 hrs