Emergence AgitationPhase 4NCT00535613
Propofol in Emergence Agitation
A Phase 4 study testing Propofol in people with Emergence Agitation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of the study is to see if a small dose of propofol given intravenously (through a needle into a vein) at the end of anesthesia can make it less likely that children will be agitated as the come out of the anesthetic. Read more about this study
- Who is it for?
- Ages 12 months to 6 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2010
- 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 12 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 12 months to 6 years old
- Planned surgery/procedure: The goal is to enroll patients who will not have pain when they awake from anesthesia. We will include patients who are having magnetic resonance imaging (MRI) under anesthesia, or an eye exam under anesthesia. We will also include those patients who are having a surgery in which a regional or caudal block is part of the planned anesthetic. This will be small orthopedic procedures in the lower extremities; or urologic or general surgical procedures below the level of the umbilicus. These patients have been chosen because the regional/caudal block should result in the patient not having pain when they awake from anesthesia.
- (The caudal block is a single epidural injection of local anesthetic that is done when the pediatric patient is under general anesthesia. It is a routine procedure that results in numbness below the level of the umbilicus, and gives relief of pain, for about 8 hours.)
- Examples of orthopedic surgeries include, but are not limited to:
- Removal of an extra digit or syndactyly repair Club foot releases Lower extremity tendon releases or lengthenings Lower extremity tendon transfers Removal of hardware
- Examples of urologic surgeries include, but are not limited to:
Show all 9Show fewer
- Circumcision or circumcision revision hypospadias repair Chordee repair Orchiopexy Orchiectomy
- Examples of general pediatric surgeries include, but are not limited to:
- Inguinal hernia repair Rectal muscle biopsies Excision of lower extremity or lower abdominal mass Burn scar releases and skin grafting
Who cannot join
- Obstructive sleep apnea-Patients with sleep apnea are not ideal candidates for removal of their endotracheal tube or laryngeal mask airway while still somewhat anesthetized. It is preferable to extubate these patients awake.
- Developmental delays-Patients with developmental delays may not interact with their environment, make eye contact, have purposeful actions, or be aware of their surroundings even when at their baseline pre-operatively. It would be difficult to evaluate these features of emergence agitation in children who demonstrate this behavior on a routine basis.
- Psychological disorders-Patients with psychological disorders may have the same issues as those with developmental delays when it comes to evaluating their behavior after anesthesia.
- Egg white allergy-Propofol is contraindicated in patients with egg white allergies due to risk of allergy to the propofol lecithin base.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Wisconsin - Madison
Madison, Wisconsin, 53726
About this study
Official title: Does a Single Dose of Propofol Decrease the Incidence of Emergence Agitation in Children?
The purpose of the study is to see if a small dose of propofol given intravenously (through a needle into a vein) at the end of anesthesia can make it less likely that children will be agitated as the come out of the anesthetic.
Read the detailed description
Emergence agitation is defined as a mental disturbance during the recovery from general anesthesia. It consists of confusion, disorientation, delusions, and hallucinations. It manifests in children as some combination of restlessness, moaning, inconsolable crying, involuntary physical activity, and thrashing about. This puts patients at risk of injuring themselves or their caregivers, causing bleeding or disruption of their surgical repair, and pulling out IVs and drains. It can be difficult to maintain necessary vital sign monitoring in these agitated patients, and constant one-on-one nursing is often required. When emergence agitation occurs, all members of the healthcare team, and the parents report dissatisfaction with the quality of the child's recovery from anesthesia.
Propofol is a commonly used intravenous anesthetic agent. Studies have compared continuous infusions of intravenous propofol versus inhalational sevoflurane for the maintenance of anesthesia. These have shown a significant decrease in the incidence of emergence agitation in the patients who received the propofol infusions. This proposed study will investigate the effects of a single bolus dose of propofol at the conclusion of a sevoflurane inhalational anesthetic.
- Conditions
- Emergence Agitation
- Being tested
- Propofol
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
IV, single bolus at completion of anesthetic, 0.1 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | propofol Receives: Drug: Propofol |
| 2 | Sham comparator | no propofol Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Emergent Agitation
Incidence of Emergent Agitation is defined as a Paediatric Anaesthesia Emergence Delirium (PAED) score above 10 at any point at the defined protocol time points (recovery, 5, 10, 15, 20, 25, or 30 minutes)
Measured: up to 30 min post surgery
Secondary outcomes (2)
Time Spent in Recovery Room
Measured: up to 1 hour post surgery
Number of Participants Who Received Medication in the Recovery Room
Measured: up to 1 hour post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2010
- Study completionDec 2010
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 Emergence AgitationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cari Meyer, MD, Principal investigator, Univeristy of Wisconsin - Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535613
- Sponsor's protocol ID
- H-2007-0069
- Status last verified
- Oct 2019
- First submitted
- 23 Sep 2007
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Single Dose of Propofol Decrease the Incidence of Emergence Agitation in Children?
- ClinicalTrials.gov ID
- NCT00535613
- Acronym / sponsor ID
- H-2007-0069
- Conditions
- Emergence Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 9 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to see if a small dose of propofol given intravenously (through a needle into a vein) at the end of anesthesia can make it less likely that children will be agitated as the come out of the anesthetic.
Detailed description
Emergence agitation is defined as a mental disturbance during the recovery from general anesthesia. It consists of confusion, disorientation, delusions, and hallucinations. It manifests in children as some combination of restlessness, moaning, inconsolable crying, involuntary physical activity, and thrashing about. This puts patients at risk of injuring themselves or their caregivers, causing bleeding or disruption of their surgical repair, and pulling out IVs and drains. It can be difficult to maintain necessary vital sign monitoring in these agitated patients, and constant one-on-one nursing is often required. When emergence agitation occurs, all members of the healthcare team, and the parents report dissatisfaction with the quality of the child's recovery from anesthesia.
Propofol is a commonly used intravenous anesthetic agent. Studies have compared continuous infusions of intravenous propofol versus inhalational sevoflurane for the maintenance of anesthesia. These have shown a significant decrease in the incidence of emergence agitation in the patients who received the propofol infusions. This proposed study will investigate the effects of a single bolus dose of propofol at the conclusion of a sevoflurane inhalational anesthetic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Propofolpropofol |
| 2 | Sham comparator | Drug: Propofolno propofol |
Who may qualify
- Ages
- 12 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age: 12 months to 6 years old
- Planned surgery/procedure: The goal is to enroll patients who will not have pain when they awake from anesthesia. We will include patients who are having magnetic resonance imaging (MRI) under anesthesia, or an eye exam under anesthesia. We will also include those patients who are having a surgery in which a regional or caudal block is part of the planned anesthetic. This will be small orthopedic procedures in the lower extremities; or urologic or general surgical procedures below the level of the umbilicus. These patients have been chosen because the regional/caudal block should result in the patient not having pain when they awake from anesthesia.
- (The caudal block is a single epidural injection of local anesthetic that is done when the pediatric patient is under general anesthesia. It is a routine procedure that results in numbness below the level of the umbilicus, and gives relief of pain, for about 8 hours.)
- Removal of an extra digit or syndactyly repair Club foot releases Lower extremity tendon releases or lengthenings Lower extremity tendon transfers Removal of hardware
- Circumcision or circumcision revision hypospadias repair Chordee repair Orchiopexy Orchiectomy
Key exclusion criteria (4 listed)
- Obstructive sleep apnea-Patients with sleep apnea are not ideal candidates for removal of their endotracheal tube or laryngeal mask airway while still somewhat anesthetized. It is preferable to extubate these patients awake.
- Developmental delays-Patients with developmental delays may not interact with their environment, make eye contact, have purposeful actions, or be aware of their surroundings even when at their baseline pre-operatively. It would be difficult to evaluate these features of emergence agitation in children who demonstrate this behavior on a routine basis.
- Psychological disorders-Patients with psychological disorders may have the same issues as those with developmental delays when it comes to evaluating their behavior after anesthesia.
- Egg white allergy-Propofol is contraindicated in patients with egg white allergies due to risk of allergy to the propofol lecithin base.
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 |
|---|---|---|
| PropofolIV, single bolus at completion of anesthetic, 0.1 ml/kg | Drug | 1, 2 |
Primary outcome
Number of Participants With Emergent Agitation
Time frame: up to 30 min post surgery
Incidence of Emergent Agitation is defined as a Paediatric Anaesthesia Emergence Delirium (PAED) score above 10 at any point at the defined protocol time points (recovery, 5, 10, 15, 20, 25, or 30 minutes)
2 secondary outcomes
Time Spent in Recovery Room
Time frame: up to 1 hour post surgery
Number of Participants Who Received Medication in the Recovery Room
Time frame: up to 1 hour post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Cari Meyer, MD principal investigator
Univeristy of Wisconsin - Madison
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 in people with Emergence Agitation, run by University of Wisconsin, Madison 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 9 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 21 Oct 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. Some participants in this study may receive a placebo. 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 9 Oct 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?
Number of Participants With Emergent Agitation (time frame: up to 30 min post surgery). 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 21 Oct 2019.