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Trial record 31 of 293 for:    retinopathy of prematurity

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
Sponsor:
Information provided by (Responsible Party):
Ayse Ulgey, 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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


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 Name: 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 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.
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 Name: sevorein




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Blood Pressure [ Time Frame: 1 Day (From start of anaesthesia till discharge from the operation room) ]
    non invasive blood pressure measured

  2. Heart rate [ Time Frame: 1 Day (From start of anaesthesia till discharge from the recovery room ) ]
    heart rate per minute were recorded



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Ages Eligible for Study:   32 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
TC Erciyes University
Investigators
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Study Director: AYŞE ÜLGEY, MD TC Erciyes University

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Responsible Party: Ayse Ulgey, assistant professor, TC Erciyes University
ClinicalTrials.gov Identifier: NCT01955135     History of Changes
Other Study ID Numbers: 2010 /145
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: October 7, 2013
Last Verified: September 2013

Keywords provided by Ayse Ulgey, TC Erciyes University:
Prematurity, Retinopathy, propofol, ketamine, sedation

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Obstetric Labor, Premature
Infant, Premature, Diseases
Eye Diseases
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases
Anesthetics
Propofol
Ketamine
Sevoflurane
Nitrous Oxide
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Analgesics, Non-Narcotic