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

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ClinicalTrials.gov Identifier: NCT01901588
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : March 8, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Strabismus Delirium on Emergence Pediatric Disorders Drug: Dexmedetomidine Other: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
Study Start Date : March 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery [ Time Frame: Length of PACU stay (around 3 hours on average) ]

Secondary Outcome Measures :
  1. Percentage of Participants Receiving Pain Medication [ Time Frame: Length of PACU stay (around 3 hours on average) ]
  2. Post-op Pain Interventions [ Time Frame: Length of PACU stay (around 3 hours on average) ]
  3. Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications [ Time Frame: Length of PACU stay (around 3 hours on average) ]
  4. Time to Arousal [ Time Frame: Length of PACU stay (around 3 hours on average) ]
  5. Time to PACU Discharge [ Time Frame: Length of PACU stay (around 3 hours on average) ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901588


Locations
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United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jason Brown, MD NYU School of Medicine
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01901588    
Other Study ID Numbers: S12-00556
First Posted: July 17, 2013    Key Record Dates
Results First Posted: March 8, 2016
Last Update Posted: July 11, 2016
Last Verified: June 2016
Keywords provided by NYU Langone Health:
strabismus
pediatric
emergence delirium
precedex/dexmedetomidine
Additional relevant MeSH terms:
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Delirium
Strabismus
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes
 Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action