Anesthesia for Retinopathy of Prematurity

TC Erciyes University

Status and phase: Completed; Phase 4

Conditions: Retinopathy

Treatments: Drug: propofol; Drug: Sevoflurane; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01955135

2010 /145

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 32 to 40 weeks old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

sedation

Active Comparator group

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.

Treatment:

Drug: Ketamine

Drug: propofol

general anesthesia

Active Comparator group

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.

Treatment:

Drug: Sevoflurane