NCT01955135

Anesthesia for Retinopathy of Prematurity

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: TC Erciyes University · Academic / Other
• Sex: All
• Age: 32 Weeks – 40 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Retinopathy

Interventions

Type	Name	Description
DRUG	Ketamine	1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation
DRUG	Sevoflurane	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
DRUG	propofol	1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2013-10-07
• Last updated: 2013-10-07