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

Phase 4

Completed

• Conditions: Delirium on Emergence; Pediatric Disorders; Strabismus
• Interventions: Drug: Dexmedetomidine; Other: Placebo

• Registration Number: NCT01901588
• Lead Sponsor: NYU Langone Health

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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-17
• Primary Completion: 2014-03
• Results First Submitted: 2016-02-08
• Results First Submitted QC: 2016-02-08
• Results First Posted: 2016-03-08
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	dexmedetomidine/precedex
Placebo	Placebo	patients receive saline solution.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery	Length of PACU stay (around 3 hours on average)

Secondary Outcome Measures

Name	Time	Method
Time to PACU Discharge	Length of PACU stay (around 3 hours on average)
Percentage of Participants Receiving Pain Medication	Length of PACU stay (around 3 hours on average)
Post-op Pain Interventions	Length of PACU stay (around 3 hours on average)
Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications	Length of PACU stay (around 3 hours on average)
Time to Arousal	Length of PACU stay (around 3 hours on average)

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States