Clinical trial NCT01901588: Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
Official title: Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Strabismus
Delirium on Emergence
Pediatric Disorders
Keywords: strabismus
pediatric
emergence delirium
precedex/dexmedetomidine
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 63
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery
timeFrame: Length of PACU stay (around 3 hours on average)
Secondary outcomes:
measure: Percentage of Participants Receiving Pain Medication
timeFrame: Length of PACU stay (around 3 hours on average)
measure: Post-op Pain Interventions
timeFrame: Length of PACU stay (around 3 hours on average)
measure: Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications
timeFrame: Length of PACU stay (around 3 hours on average)
measure: Time to Arousal
timeFrame: Length of PACU stay (around 3 hours on average)
measure: Time to PACU Discharge
timeFrame: Length of PACU stay (around 3 hours on average)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Jason Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: