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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01901588
First received: April 17, 2013
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.

Condition Intervention Phase
Strabismus
Delirium on Emergence
Pediatric Disorders
Drug: Dexmedetomidine
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery [ Time Frame: Length of PACU stay (around 3 hours on average) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants Receiving Pain Medication [ Time Frame: Length of PACU stay (around 3 hours on average) ] [ Designated as safety issue: No ]
  • Post-op Pain Interventions [ Time Frame: Length of PACU stay (around 3 hours on average) ] [ Designated as safety issue: No ]
  • Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications [ Time Frame: Length of PACU stay (around 3 hours on average) ] [ Designated as safety issue: No ]
  • Time to Arousal [ Time Frame: Length of PACU stay (around 3 hours on average) ] [ Designated as safety issue: No ]
  • Time to PACU Discharge [ Time Frame: Length of PACU stay (around 3 hours on average) ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: March 2012
Estimated Study Completion Date: May 2016
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine
dexmedetomidine/precedex
Drug: Dexmedetomidine
intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
Other Name: Precedex
Placebo Comparator: Placebo
patients receive saline solution.
Other: Placebo
intraoperative dose of intravenous placebo
Other Name: saline solution

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

Ages Eligible for Study:   1 Year to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901588

Locations
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Jason Brown, MD NYU School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01901588     History of Changes
Other Study ID Numbers: S12-00556 
Study First Received: April 17, 2013
Results First Received: February 8, 2016
Last Updated: April 5, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
strabismus
pediatric
emergence delirium
precedex/dexmedetomidine

Additional relevant MeSH terms:
Delirium
Strabismus
Confusion
Cranial Nerve Diseases
Eye Diseases
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurocognitive Disorders
Neurologic Manifestations
Ocular Motility Disorders
Signs and Symptoms
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 26, 2016