NYU Langone Medical Center
New York, 10016, United States
NCT Number: NCT01901588
This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.
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Notify Me1 year–7 year
All sexes
Interventional
Phase 4
New York, 10016, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
Other names: Precedex
intraoperative dose of intravenous placebo
Other names: saline solution
Time frame: Length of PACU stay (around 3 hours on average)
Time frame: Length of PACU stay (around 3 hours on average)
Time frame: Length of PACU stay (around 3 hours on average)
Time frame: Length of PACU stay (around 3 hours on average)
Time frame: Length of PACU stay (around 3 hours on average)
Time frame: Length of PACU stay (around 3 hours on average)
NYU Langone Health
Other
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