NCT01901588

Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Not accepted

Summary

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: 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

Conditions

• Strabismus
• Delirium on Emergence
• Pediatric Disorders

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
OTHER	Placebo	intraoperative dose of intravenous placebo

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-03-01
• Completion: 2016-05-01
• First posted: 2013-07-17
• Last updated: 2016-07-11
• Results posted: 2016-03-08

Locations

1 site across 1 country: United States