Strabismus Clinical Trial
Official title:
Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
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