Anesthesia for Retinopathy of Prematurity

Sponsor

TC Erciyes University (Other)

Overall Status

Completed

CT.gov ID

NCT01955135

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinopathy	Drug: Ketamine Drug: Sevoflurane Drug: propofol	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: sedation 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.	Drug: Ketamine 1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation Other Names: ketalar, 50mg/ml Drug: propofol 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol Other Names: pofol
Active Comparator: general anesthesia 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.	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 Other Names: sevorein

Arm

Intervention/Treatment

Active Comparator: sedation

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.

Drug: Ketamine

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

Other Names:

ketalar, 50mg/ml

Drug: propofol

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

Other Names:

pofol

Active Comparator: general anesthesia

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.

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

Other Names:

sevorein

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

32 Weeks to 40 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.