StrabismusPhase 4NCT01901588
Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
A Phase 4 study testing Dexmedetomidine in people with Strabismus and Delirium on Emergence, run by NYU Langone Health at 1 site in United States.
Trial summary
This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Strabismus, Delirium on Emergence, Pediatric Disorders
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2016
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status of I or II
- male or female, aged 1-7
- has no significant lab abnormalities
Who cannot join
- ASA physical status of III, IV or V
- Presence of medicated behavioral disorder
- Subjects for which dexmedetomidine, opiates, benzodiazepines or inhalational anesthetics are contraindicated.
- Parental refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.
Read the detailed description
Emergence delirium (ED) is a complex behavioral disturbance characterized by psychomotor agitation, perceptual disturbances, delusions, and disorientation during recovery from general anesthesia. In the population of subjects who undergo strabismus surgery, there are multiple factors that may increase the risk of ED. These include age, typically preschool children aged 1-7 years, rapid surgical times with rapid awakening, use of sevoflurane as the primary anesthetic, and surgically-induced postoperative visual disturbance. The aims of this study are: 1) To examine whether post-induction treatment with an α-2 receptor agonist, precedex (dexmedetomidine), decreases postoperative emergence agitation after strabismus surgery compared to placebo, and 2) to determine whether treatment has any effect on postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU discharge. We hypothesize that precedex will attenuate the ED response greater than placebo or a lower dose after strabismus surgery and will reduce PACU pain scores without increasing PACU length of stay.
Inclusion:
- Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA) physical status I-II iii. No significant laboratory abnormalities
Exclusion:
- Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates, benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal
- Conditions
- Strabismus, Delirium on Emergence, Pediatric Disorders
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- strabismus, pediatric, emergence delirium, precedex/dexmedetomidine
- Medical subject headings
- Strabismus, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
PlaceboOther
Also called saline solution
intraoperative dose of intravenous placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | dexmedetomidine/precedex Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | patients receive saline solution. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery
Measured: Length of PACU stay (around 3 hours on average)
Secondary outcomes (5)
Percentage of Participants Receiving Pain Medication
Measured: Length of PACU stay (around 3 hours on average)
Post-op Pain Interventions
Measured: Length of PACU stay (around 3 hours on average)
Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications
Measured: Length of PACU stay (around 3 hours on average)
Time to Arousal
Measured: Length of PACU stay (around 3 hours on average)
Time to PACU Discharge
Measured: Length of PACU stay (around 3 hours on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionMay 2016
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 StrabismusStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Brown, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901588
- Sponsor's protocol ID
- S12-00556
- Status last verified
- Jun 2016
- First submitted
- 17 Apr 2013
- Last updated
- 11 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
- ClinicalTrials.gov ID
- NCT01901588
- Acronym / sponsor ID
- S12-00556
- Conditions
- Strabismus, Delirium on Emergence, Pediatric Disorders
- Keywords
- strabismus, pediatric, emergence delirium, precedex/dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Posted 8 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.
Detailed description
Emergence delirium (ED) is a complex behavioral disturbance characterized by psychomotor agitation, perceptual disturbances, delusions, and disorientation during recovery from general anesthesia. In the population of subjects who undergo strabismus surgery, there are multiple factors that may increase the risk of ED. These include age, typically preschool children aged 1-7 years, rapid surgical times with rapid awakening, use of sevoflurane as the primary anesthetic, and surgically-induced postoperative visual disturbance. The aims of this study are: 1) To examine whether post-induction treatment with an α-2 receptor agonist, precedex (dexmedetomidine), decreases postoperative emergence agitation after strabismus surgery compared to placebo, and 2) to determine whether treatment has any effect on postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU discharge. We hypothesize that precedex will attenuate the ED response greater than placebo or a lower dose after strabismus surgery and will reduce PACU pain scores without increasing PACU length of stay.
Inclusion:
- Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA) physical status I-II iii. No significant laboratory abnormalities
Exclusion:
- Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates, benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidinedexmedetomidine/precedex |
| Placebo | Placebo comparator | Other: Placebopatients receive saline solution. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status of I or II
- male or female, aged 1-7
- has no significant lab abnormalities
Key exclusion criteria (4 listed)
- ASA physical status of III, IV or V
- Presence of medicated behavioral disorder
- Subjects for which dexmedetomidine, opiates, benzodiazepines or inhalational anesthetics are contraindicated.
- Parental refusal
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 |
|---|---|---|
| DexmedetomidineAlso: Precedexintravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes | Drug | Dexmedetomidine |
| PlaceboAlso: saline solutionintraoperative dose of intravenous placebo | Other | Placebo |
Primary outcome
Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery
Time frame: Length of PACU stay (around 3 hours on average)
5 secondary outcomes
Percentage of Participants Receiving Pain Medication
Time frame: Length of PACU stay (around 3 hours on average)
Post-op Pain Interventions
Time frame: Length of PACU stay (around 3 hours on average)
Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications
Time frame: Length of PACU stay (around 3 hours on average)
Time to Arousal
Time frame: Length of PACU stay (around 3 hours on average)
Time to PACU Discharge
Time frame: Length of PACU stay (around 3 hours on average)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- 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.
Jason Brown, MD principal investigator
NYU School of Medicine
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 Dexmedetomidine in people with Strabismus and Delirium on Emergence, run by NYU Langone Health 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 3 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 11 Jul 2016. 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 8 Mar 2016). 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?
Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery (time frame: Length of PACU stay (around 3 hours on average)). 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 11 Jul 2016.