Anesthesia for Retinopathy of Prematurity

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01955135

Enrollment

Registered

2013-10-07

Start date

2010-09-30

Completion date

2013-03-31

Last updated

2013-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy

Keywords

Prematurity, Retinopathy, propofol, ketamine, sedation

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.

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.

Interventions

DRUGKetamine

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

DRUGSevoflurane

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

DRUGpropofol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

32 Weeks to 40 Weeks

Healthy volunteers

Inclusion criteria

* infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of ROP

Exclusion criteria

* The

Design outcomes

Primary

Measure	Time frame	Description
Respiratory failure after retinopathy of prematurity surgery in premature infants.	1 Day (From end of anaesthesia till discharge from the recovery room )	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.

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026