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Anesthesia for Retinopathy of Prematurity

NCT ID: NCT01955135

Last Updated: 2013-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Retinopathy

Keywords

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Prematurity, Retinopathy, propofol, ketamine, sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

propofol

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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

Interventions

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Ketamine

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

Intervention Type 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

Intervention Type DRUG

propofol

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

Intervention Type DRUG

Other Intervention Names

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ketalar, 50mg/ml sevorein pofol

Eligibility Criteria

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Inclusion Criteria

* infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of ROP

Exclusion Criteria

* 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.
Minimum Eligible Age

32 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ayse Ulgey

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AYŞE ÜLGEY, MD

Role: STUDY_DIRECTOR

TC Erciyes University

Other Identifiers

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2010 /145

Identifier Type: -

Identifier Source: org_study_id