Anesthesia for Retinopathy of Prematurity

Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955135
• Other study ID #: 2010 /145
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2013
• Last updated: September 27, 2013
• Start date: September 2010
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 32 Weeks to 40 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy
• Retinopathy of Prematurity

Intervention

Drug:
• Ketamine
1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation
• 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
• propofol
1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory failure after retinopathy of prematurity surgery in premature infants.	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.	1 Day (From end of anaesthesia till discharge from the recovery room )	No
Secondary	Blood Pressure	non invasive blood pressure measured	1 Day (From start of anaesthesia till discharge from the operation room)	No
Secondary	Heart rate	heart rate per minute were recorded	1 Day (From start of anaesthesia till discharge from the recovery room )	No