RetinopathyPhase 4NCT01955135
Anesthesia for Retinopathy of Prematurity
A Phase 4 study testing Ketamine, Sevoflurane and propofol in people with Retinopathy, run by TC Erciyes University.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 40 weeks
- Conditions the study is for
- Retinopathy
- What is being tested?
- Ketamine, Sevoflurane and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of ROP
Who cannot join
- 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.
About this study
Official title: DECREASING THE NEED FOR MECHANICAL VENTILATION AFTER RETINOPATHY OF PREMATURITY SURGERY: Sedation vs General Anesthesia
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.
Read the 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.
- Conditions
- Retinopathy
- Being tested
- Ketamine, Sevoflurane, propofol
- Keywords
- Prematurity, Retinopathy, propofol, ketamine, sedation
- Medical subject headings
- Retinal Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called ketalar, 50mg/ml
1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation
SevofluraneDrug
Also called sevorein
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
propofolDrug
Also called pofol
1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol
| Study group | Role | What they receive |
|---|---|---|
| sedation | Active comparator | 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. Receives: Drug: Ketamine; Drug: propofol |
| general anesthesia | Active comparator | 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. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory failure after retinopathy of prematurity surgery in premature infants.
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.
Measured: 1 Day (From end of anaesthesia till discharge from the recovery room )
Secondary outcomes (2)
Blood Pressure
non invasive blood pressure measured
Measured: 1 Day (From start of anaesthesia till discharge from the operation room)
Heart rate
heart rate per minute were recorded
Measured: 1 Day (From start of anaesthesia till discharge from the recovery room )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ulgey, TC Erciyes University
- Investigators
- AYŞE ÜLGEY, MD, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955135
- Sponsor's protocol ID
- 2010 /145
- Status last verified
- Sep 2013
- First submitted
- 4 Sep 2013
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DECREASING THE NEED FOR MECHANICAL VENTILATION AFTER RETINOPATHY OF PREMATURITY SURGERY: Sedation vs General Anesthesia
- ClinicalTrials.gov ID
- NCT01955135
- Acronym / sponsor ID
- 2010 /145
- Conditions
- Retinopathy
- Keywords
- Prematurity, Retinopathy, propofol, ketamine, sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sedation | Active comparator | Drug: Ketamine, Drug: propofolThe 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. |
| general anesthesia | Active comparator | Drug: SevofluraneIn 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. |
Who may qualify
- Ages
- 32 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of ROP
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: ketalar, 50mg/ml1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation | Drug | sedation |
| SevofluraneAlso: sevoreinanesthesia 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 | Drug | general anesthesia |
| propofolAlso: pofol1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol | Drug | sedation |
Primary outcome
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.
2 secondary outcomes
Blood Pressure
Time frame: 1 Day (From start of anaesthesia till discharge from the operation room)
Heart rate
Time frame: 1 Day (From start of anaesthesia till discharge from the recovery room )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYŞE ÜLGEY, MD study director
TC Erciyes University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine, Sevoflurane and propofol in people with Retinopathy, run by TC Erciyes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory failure after retinopathy of prematurity surgery in premature infants. (time frame: 1 Day (From end of anaesthesia till discharge from the recovery room )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2013.