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Clinical Trials/NCT01955135
NCT01955135
Completed
Phase 4

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

TC Erciyes University0 sites60 target enrollmentSeptember 2010

Overview

Phase
Phase 4
Intervention
Ketamine
Conditions
Retinopathy
Sponsor
TC Erciyes University
Enrollment
60
Primary Endpoint
Respiratory failure after retinopathy of prematurity surgery in premature infants.
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
March 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ayse Ulgey

assistant professor

TC Erciyes University

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: Ketamine

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.

Intervention: propofol

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.

Intervention: Sevoflurane

Outcomes

Primary Outcomes

Respiratory failure after retinopathy of prematurity surgery in premature infants.

Time Frame: 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 Outcomes

  • Blood Pressure(1 Day (From start of anaesthesia till discharge from the operation room))
  • Heart rate(1 Day (From start of anaesthesia till discharge from the recovery room ))

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