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

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

Study Overview

• Status: Completed
• Conditions: Delirium on Emergence; Strabismus; Pediatric Disorders
• Intervention / Treatment: Drug: Dexmedetomidine; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dexmedetomidine; dexmedetomidine/precedex	Drug: Dexmedetomidine; intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes; Other Names: Precedex
PLACEBO_COMPARATOR: Placebo; patients receive saline solution.	Other: Placebo; intraoperative dose of intravenous placebo; Other Names: saline solution

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
Time to PACU Discharge	Length of PACU stay (around 3 hours on average)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jason Brown, MD, NYU School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (ESTIMATE): July 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: pediatric; strabismus; emergence delirium; precedex/dexmedetomidine
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Eye Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cranial Nerve Diseases; Ocular Motility Disorders; Delirium; Strabismus; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: S12-00556