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

NYU Langone Health

Status and phase

Completed

Phase 4

Conditions

Strabismus

Pediatric Disorders

Delirium on Emergence

Treatments

Drug: Dexmedetomidine

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01901588

S12-00556

Details and patient eligibility

About

This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.

Full 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

Enrollment

63 patients

Sex

All

Ages

1 to 7 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

ASA physical status of I or II
male or female, aged 1-7
has no significant lab abnormalities

Exclusion criteria

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