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

Strabismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01901588
• Other study ID #: S12-00556
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 17, 2013
• Last updated: February 8, 2016
• Start date: March 2012
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: March 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium
• Delirium on Emergence
• Pediatric Disorders
• Strabismus

Intervention

Drug:
• Dexmedetomidine
intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes

Other:
• Placebo
intraoperative dose of intravenous placebo

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery		Length of PACU stay (around 3 hours on average)	No
Secondary	Percentage of Participants Receiving Pain Medication		Length of PACU stay (around 3 hours on average)	No
Secondary	Number of Post-op Pain Interventions		Length of PACU stay (around 3 hours on average)	No
Secondary	Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications		Length of PACU stay (around 3 hours on average)	No
Secondary	Time to Arousal		Length of PACU stay (around 3 hours on average)	No
Secondary	Time to PACU Discharge		Length of PACU stay (around 3 hours on average)	No