Delirium on EmergencePhase 4NCT02111447
Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI
A Phase 4 study testing Propofol, Sevoflurane and Isoflurane in people with Delirium on Emergence, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. This occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Delirium on Emergence
- What is being tested?
- Propofol, Sevoflurane and Isoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-12yrs,
- ASA Class I-II,
- Fasting,
- Unmedicated,
- Elective MRI scan
Who cannot join
- Cognitive impairment,
- On psychotropic medications,
- Taking multiple (>2) antiepileptic medications,
- Requiring endotracheal intubation for GA
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Chidren's Hospital Of Buffalo
Buffalo, New York, 14222
About this study
Official title: Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI: Comparative Study Using Propofol, Sevoflurane and Isoflurane
Children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. This occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. However, agitation after anesthesia in children may be difficult to distinguish from pain; accordingly studies are ideally designed during MRI to obviate the contribution of pain during emergence. Airway complications have been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs. Whether the airway complications were due to the LMA or the isoflurane was unclear. Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane compared with IV propofol and 2. airway complications after LMA or nasal prongs.
Read the detailed description
180 children, ASA physical status 1 or 2 will be recruited for elective MRI scan. Randomized after consent is obtained to one of four groups. Anxiety will be assessed preoperatively using the modified Yale preoperative anxiety scale. Children will be accompanied by one parent to MRI scanner where monitors are applied. All children will have anesthesia induced with nitrous oxide and oxygen followed by sevoflurane until IV is established. Thereupon, they will be managed by their randomization assignment. The propofol pump will be concealed at all times. If propofol was used, it will be disconnected from the patient and residual propofol in the line flushed so prevent unblinding the patient's assignment. A blinded observer will be present to evaluate the patient when emergence begins. The single blinded observer will follow the patient from the MRI scanner through recovery room evaluating vital signs as well as emergence delirium (using the PAED scale). A PAED score > 12 at any time during emergence period will confirm the diagnosis of emergence delirium. After discharge from hospital, a post-discharge questionnaire will be completed at 12, 24 and 48 hours after discharge. All parents will be called to retrieve the questionnaire results after 48 hours after discharge from hospital.
- Conditions
- Delirium on Emergence
- Being tested
- Propofol, Sevoflurane, Isoflurane
- Keywords
- children, sevoflurane, isoflurane, propofol, anesthesia, MRI, delirium
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan 1%
Propofol infusion with nasal oxygen
PropofolDrug
Also called 1% Diprivan
Propofol infusion with an LMA
SevofluraneDrug
Also called Sevorane
Sevoflurane with an LMA
IsofluraneDrug
Also called Forane
Isoflurane with an LMA
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane, propofol, Nasal oxygen | Active comparator | After securing the IV, sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. A bolus of propofol will not be administered. Oxygen will be delivered via nasal prongs at 2 liters per minute. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min also after 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be administered if the child moves or if signs of light anesthesia are noticed. The propofol infusion may also be increased in response to light anesthesia. Receives: Drug: Propofol |
| Sevoflurane, Propofol, LMA | Active comparator | After securing the IV, weight appropriate LMA will be inserted and sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. Oxygen in air will be delivered via LMA. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min after another 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be given if the child moves or exhibits signs of light anesthesia. The propofol infusion may also be increased in response to light anesthesia. Receives: Drug: Propofol; Drug: Sevoflurane |
| Sevoflurane, sevoflurane, LMA | Active comparator | After securing the IV, weight appropriate LMA will be inserted and sevoflurane continued at 3% inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. The sevoflurane may be increased or decreased in 0.5% increments as needed. Receives: Drug: Sevoflurane |
| Sevoflurane, isoflurane, LMA | Active comparator | After securing the IV, weight appropriate LMA will be inserted , sevoflurane will be discontinued and isoflurane will be administered at 2 % inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. Isoflurane may be increased or decreased in 0.5% increments as needed. Receives: Drug: Sevoflurane; Drug: Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Delirium on Emergence
Delirium on emergence will be assessed using the PAED scale by a blinded observer in the post anesthesia period. A score >12 constitutes a diagnosis of delirium in children. The post anesthesia period is usually <2 hours after anesthesia.
Measured: WIthin 2 hours of emergence from anesthesia
Secondary outcomes (1)
Incidence of Airway Complications
All airway reflex responses including airway obstruction breath holding, coughing, laryngospasm, desaturation <92% for >15 s regardless of the cause, bronchospasm, secretions and hiccups
Measured: WIthin 2 hours of emergence from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Not enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Delirium on EmergenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerrold Lerman, State University of New York at Buffalo
- Investigators
- Jerrold Lerman, MD, Principal investigator, Women And Childrens Hospital Of BuffaloChristopher Heard, MD, Principal investigator, Women And Childrens Hospital Of Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111447
- Sponsor's protocol ID
- 412889-6
- Status last verified
- Jul 2019
- First submitted
- 9 Apr 2014
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI: Comparative Study Using Propofol, Sevoflurane and Isoflurane
- ClinicalTrials.gov ID
- NCT02111447
- Acronym / sponsor ID
- 412889-6
- Conditions
- Delirium on Emergence
- Keywords
- children, sevoflurane, isoflurane, propofol, anesthesia, MRI, delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. This occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. However, agitation after anesthesia in children may be difficult to distinguish from pain; accordingly studies are ideally designed during MRI to obviate the contribution of pain during emergence. Airway complications have been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs. Whether the airway complications were due to the LMA or the isoflurane was unclear. Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane compared with IV propofol and 2. airway complications after LMA or nasal prongs.
Detailed description
180 children, ASA physical status 1 or 2 will be recruited for elective MRI scan. Randomized after consent is obtained to one of four groups. Anxiety will be assessed preoperatively using the modified Yale preoperative anxiety scale. Children will be accompanied by one parent to MRI scanner where monitors are applied. All children will have anesthesia induced with nitrous oxide and oxygen followed by sevoflurane until IV is established. Thereupon, they will be managed by their randomization assignment. The propofol pump will be concealed at all times. If propofol was used, it will be disconnected from the patient and residual propofol in the line flushed so prevent unblinding the patient's assignment. A blinded observer will be present to evaluate the patient when emergence begins. The single blinded observer will follow the patient from the MRI scanner through recovery room evaluating vital signs as well as emergence delirium (using the PAED scale). A PAED score > 12 at any time during emergence period will confirm the diagnosis of emergence delirium. After discharge from hospital, a post-discharge questionnaire will be completed at 12, 24 and 48 hours after discharge. All parents will be called to retrieve the questionnaire results after 48 hours after discharge from hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane, propofol, Nasal oxygen | Active comparator | Drug: PropofolAfter securing the IV, sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. A bolus of propofol will not be administered. Oxygen will be delivered via nasal prongs at 2 liters per minute. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min also after 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be administered if the child moves or if signs of light anesthesia are noticed. The propofol infusion may also be increased in response to light anesthesia. |
| Sevoflurane, Propofol, LMA | Active comparator | Drug: Propofol, Drug: SevofluraneAfter securing the IV, weight appropriate LMA will be inserted and sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. Oxygen in air will be delivered via LMA. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min after another 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be given if the child moves or exhibits signs of light anesthesia. The propofol infusion may also be increased in response to light anesthesia. |
| Sevoflurane, sevoflurane, LMA | Active comparator | Drug: SevofluraneAfter securing the IV, weight appropriate LMA will be inserted and sevoflurane continued at 3% inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. The sevoflurane may be increased or decreased in 0.5% increments as needed. |
| Sevoflurane, isoflurane, LMA | Active comparator | Drug: Sevoflurane, Drug: IsofluraneAfter securing the IV, weight appropriate LMA will be inserted , sevoflurane will be discontinued and isoflurane will be administered at 2 % inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. Isoflurane may be increased or decreased in 0.5% increments as needed. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 2-12yrs,
- ASA Class I-II,
- Fasting,
- Unmedicated,
- Elective MRI scan
Key exclusion criteria (4 listed)
- Cognitive impairment,
- On psychotropic medications,
- Taking multiple (>2) antiepileptic medications,
- Requiring endotracheal intubation for GA
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 |
|---|---|---|
| PropofolAlso: Diprivan 1%Propofol infusion with nasal oxygen | Drug | Sevoflurane, Propofol, LMA, Sevoflurane, propofol, Nasal oxygen |
| PropofolAlso: 1% DiprivanPropofol infusion with an LMA | Drug | Sevoflurane, propofol, Nasal oxygen |
| SevofluraneAlso: SevoraneSevoflurane with an LMA | Drug | Sevoflurane, Propofol, LMA, Sevoflurane, isoflurane, LMA, Sevoflurane, sevoflurane, LMA |
| IsofluraneAlso: ForaneIsoflurane with an LMA | Drug | Sevoflurane, isoflurane, LMA |
Primary outcome
Incidence of Delirium on Emergence
Time frame: WIthin 2 hours of emergence from anesthesia
Delirium on emergence will be assessed using the PAED scale by a blinded observer in the post anesthesia period. A score >12 constitutes a diagnosis of delirium in children. The post anesthesia period is usually <2 hours after anesthesia.
1 secondary outcome
Incidence of Airway Complications
Time frame: WIthin 2 hours of emergence from anesthesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jerrold Lerman, MD principal investigator
Women And Childrens Hospital Of Buffalo
Christopher Heard, MD principal investigator
Women And Childrens Hospital Of Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol, Sevoflurane and Isoflurane in people with Delirium on Emergence, run by State University of New York at Buffalo at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Delirium on Emergence (time frame: WIthin 2 hours of emergence from anesthesia). 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 23 Jul 2019.