Anesthesia for Retinopathy of Prematurity

Phase 4

Completed

• Conditions: Retinopathy
• Interventions: Drug: Sevoflurane; Drug: Ketamine; Drug: propofol

• Registration Number: NCT01955135
• Lead Sponsor: TC Erciyes University

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-27
• Last Update Submitted: 2013-09-27
• Study First Posted: 2013-10-07
• Last Update Posted: 2013-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general anesthesia	Sevoflurane	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.
sedation	Ketamine	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.
sedation	propofol	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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