Anesthesia for Retinopathy of Prematurity

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Retinopathy

Intervention / Treatment
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* Drug: Ketamine
* Drug: Sevoflurane
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 40 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sedation<br>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. | Drug: Ketamine<br>* 1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation<br>* Other names: ketalar, 50mg/ml;Drug: propofol<br>* 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol<br>* Other names: pofol;|
| Active Comparator: general anesthesia<br>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. | Drug: Sevoflurane<br>* 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<br>* Other names: sevorein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 Day (From end of anaesthesia till discharge from the recovery room ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | non invasive blood pressure measured | 1 Day (From start of anaesthesia till discharge from the operation room) | 
| Heart rate | heart rate per minute were recorded | 1 Day (From start of anaesthesia till discharge from the recovery room ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prematurity, Retinopathy, propofol, ketamine, sedation