Anesthesia for Retinopathy of Prematurity
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|ClinicalTrials.gov Identifier: NCT01955135|
Recruitment Status : Completed
First Posted : October 7, 2013
Last Update Posted : October 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Retinopathy||Drug: Ketamine Drug: Sevoflurane Drug: propofol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||DECREASING THE NEED FOR MECHANICAL VENTILATION AFTER RETINOPATHY OF PREMATURITY SURGERY: Sedation vs General Anesthesia|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||March 2013|
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.
1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation
Other Name: ketalar, 50mg/ml
1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol
Other Name: 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.
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 Name: sevorein
- 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.
- Blood Pressure [ Time Frame: 1 Day (From start of anaesthesia till discharge from the operation room) ]non invasive blood pressure measured
- Heart rate [ Time Frame: 1 Day (From start of anaesthesia till discharge from the recovery room ) ]heart rate per minute were recorded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955135
|Study Director:||AYŞE ÜLGEY, MD||TC Erciyes University|