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Completed

NCT Number: NCT01955135

Anesthesia for Retinopathy of Prematurity

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.

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Key information

Conditions

Retinopathy Eye Diseases Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Retinal Diseases Urogenital Diseases

Age range

32 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation

Other names: ketalar, 50mg/ml

Sevoflurane

Drug

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

Other names: sevorein

Propofol

Drug

1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol

Other names: pofol

Primary outcomes

  1. Respiratory failure after retinopathy of prematurity surgery in premature infants.

    Time frame: 1 Day (From end of anaesthesia till discharge from the recovery room )

    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 outcomes

  1. Blood Pressure

    Time frame: 1 Day (From start of anaesthesia till discharge from the operation room)

    non invasive blood pressure measured

  2. Heart rate

    Time frame: 1 Day (From start of anaesthesia till discharge from the recovery room )

    heart rate per minute were recorded

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

DECREASING THE NEED FOR MECHANICAL VENTILATION AFTER RETINOPATHY OF PREMATURITY SURGERY: Sedation vs General Anesthesia

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Oct 7, 2013
Registry last updated
Oct 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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