Anesthesia for Retinopathy of Prematurity

Brief 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.

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Sevoflurane
  • Drug: propofol

Condition or Disease

  • Retinopathy

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 32 Weeks to 40 Weeks   (Child)
Enrollment: 60 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Sep 10, 2020
Primary Completion: Dec 12, 2020
Completion Date: Mar 13, 2020
Study First Posted: Oct 07, 2013
Results First Posted: Aug 31, 2020
Last Updated: Oct 07, 2013

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All

More Details

NCT Number: NCT01955135
Other IDs: 2010 /145
Study URL: https://ClinicalTrials.gov/show/NCT01955135
Last updated: Jan 27, 2021