Anesthesia for Retinopathy of Prematurity

Phase 4CompletedNCT01955135

TC Erciyes University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Retinopathy

Interventions

KetamineDRUG

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

SevofluraneDRUG

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

propofolDRUG

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

Eligibility

Sex: ALLMin age: 32 WeeksMax age: 40 Weeks

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Blood Pressure

non invasive blood pressure measured

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

Heart rate

heart rate per minute were recorded

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

Data from ClinicalTrials.gov

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