A Phase 4 interventional study of Dexmedetomidine and Placebo in Strabismus, Delirium on Emergence and Pediatric Disorders, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2016-07-11.
Sponsored by NYU Langone Health · Phase 4, Interventional, and Prevention
This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.
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:
i. Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA) physical status I-II iii. No significant laboratory abnormalities
Exclusion:
i. Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates, benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal
159 studies on the registry are indexed under Strabismus; 31 are open to participants now.
This study's enrollment of 63 is close to the median of 60 across 98 interventional studies indexed under Strabismus.
Browse Strabismus studies →NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.
Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.
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Exclusion Criteria:
dexmedetomidine/precedex
Drug: Dexmedetomidine
patients receive saline solution.
Other: Placebo
intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
Also known as: Precedex
intraoperative dose of intravenous placebo
Also known as: saline solution
Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery
Time frame: Length of PACU stay (around 3 hours on average)
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)
Patient's familes were approached on the day of surgery and spoken to privately in the pre-op area. Fliers were placed at the phthalmalogist's offices so were generally aware of the study ahead of time.
| Milestone | Dexmedetomidine | Placebo |
|---|---|---|
| Started | 32 | 31 |
| Completed | 32 | 31 |
| Not completed | 0 | 0 |
| percentage of participants | Dexmedetomidine | Placebo |
|---|---|---|
| Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery | 50 | 48 |
| percentage of participants | Dexmedetomidine | Placebo |
|---|---|---|
| Percentage of Participants Receiving Pain Medication | 50 | 66 |
| number of pain interventions/group | Dexmedetomidine | Placebo |
|---|---|---|
| Post-op Pain Interventions | 18 | 30 |
| percentage of participants | Dexmedetomidine | Placebo |
|---|---|---|
| Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications | 0 | 14 |
| minutes | Dexmedetomidine | Placebo |
|---|---|---|
| Time to Arousal | 60 ± 36 | 40 ± 39 |
| minutes | Dexmedetomidine | Placebo |
|---|---|---|
| Time to PACU Discharge | 186 ± 64 | 173 ± 60 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexmedetomidine | — | 0/32 (0%) | 0/32 (0%) |
| Placebo | — | 0/31 (0%) | 0/31 (0%) |
| Age, Categorical(Participants) | Dexmedetomidine | Placebo | Total |
|---|---|---|---|
| <=18 years | 32 | 31 | 63 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Dexmedetomidine | Placebo | Total |
|---|---|---|---|
| Female | 12 | 16 | 28 |
| Male | 20 | 15 | 35 |
| Race/Ethnicity, Customized(participants) | Dexmedetomidine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaskan | 0 | 0 | 0 |
| Asian or Pacific Islander | 1 | 2 | 3 |
| Black, Not of Hispanic-American Origin | 2 | 1 | 3 |
| Hispanic-American | 1 | 0 | 1 |
| White, not of Hispanic-American Origin | 23 | 22 | 45 |
| Other or Unknown | 5 | 6 | 11 |
The record gives a start of Mar 2012, a primary completion of Mar 2014 and a completion of May 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2016, 2 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine