Emergence AgitationNCT00990769
The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children
A study testing Depth of anesthesia in people with Emergence Agitation, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not been studied. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Depth of anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2010
- Phase
- Interventional
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 2 - 8 (inclusive) undergoing ophthalmologic surgery
- American Society of Anesthesiology (ASA) physical status 1 or 2
Who cannot join
- Surgery precluding placement of BIS monitor
- Non-English speaking, until additional language consent forms are approved
- Previous history of severe emergence agitation
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center - Eye Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not been studied. The study will randomize 40 children undergoing ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.
- Conditions
- Emergence Agitation
- Being tested
- Depth of anesthesia
- Keywords
- Emergence delirium, Bispectral Index, Depth of anesthesia
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depth of anesthesiaOther
The intervention in this study is the titration of the depth of anesthesia according to the BIS monitor, as maintained by a combination of routine anesthetic agents (nitrous oxide, sevoflurane, and fentanyl).
| Study group | Role | What they receive |
|---|---|---|
| High-normal BIS ("Lighter" anesthesia) | Experimental | Depth of anesthesia is titrated to a BIS of 55-60 Receives: Other: Depth of anesthesia |
| Low-normal BIS ("Deeper" anesthesia) | Experimental | Depth of anesthesia is maintained at a BIS level of 40-45 Receives: Other: Depth of anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)
The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation.
Measured: Within 30 minutes of arrival in recovery room
Secondary outcomes (2)
Time to Emergence From Anesthesia
The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.
Measured: After the completion of surgery
Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)
Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study.
Measured: Within 30 minutes of arrival in 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 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Frederick, Duke University
- Investigators
- Heather J Frederick, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990769
- Sponsor's protocol ID
- Pro00015531
- Status last verified
- May 2013
- First submitted
- 5 Oct 2009
- Last updated
- 31 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children
- ClinicalTrials.gov ID
- NCT00990769
- Acronym / sponsor ID
- Pro00015531
- Conditions
- Emergence Agitation
- Keywords
- Emergence delirium, Bispectral Index, Depth of anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Posted 31 May 2013
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 this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not been studied. The study will randomize 40 children undergoing ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-normal BIS ("Lighter" anesthesia) | Experimental | Other: Depth of anesthesiaDepth of anesthesia is titrated to a BIS of 55-60 |
| Low-normal BIS ("Deeper" anesthesia) | Experimental | Other: Depth of anesthesiaDepth of anesthesia is maintained at a BIS level of 40-45 |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children age 2 - 8 (inclusive) undergoing ophthalmologic surgery
- American Society of Anesthesiology (ASA) physical status 1 or 2
Key exclusion criteria (3 listed)
- Surgery precluding placement of BIS monitor
- Non-English speaking, until additional language consent forms are approved
- Previous history of severe emergence agitation
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 |
|---|---|---|
| Depth of anesthesiaThe intervention in this study is the titration of the depth of anesthesia according to the BIS monitor, as maintained by a combination of routine anesthetic agents (nitrous oxide, sevoflurane, and fentanyl). | Other | High-normal BIS ("Lighter" anesthesia), Low-normal BIS ("Deeper" anesthesia) |
Primary outcome
Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)
Time frame: Within 30 minutes of arrival in recovery room
The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation.
2 secondary outcomes
Time to Emergence From Anesthesia
Time frame: After the completion of surgery
Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)
Time frame: Within 30 minutes of arrival in recovery room
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- 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.
Heather J Frederick, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depth of anesthesia in people with Emergence Agitation, run by Duke University 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 2 inclusion and 3 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 31 May 2013. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2013). 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?
Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit) (time frame: Within 30 minutes of arrival in 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 31 May 2013.