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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Wanda Chin, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01901588
First received: April 17, 2013
Last updated: March 26, 2014
Last verified: March 2014
  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:
  • Efficacy of Single-Shot Dexmedetomidine versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery [ Time Frame: two years ] [ Designated as safety issue: No ]
    To examine whether post-induction treatment with an α-2 receptor agonist, dexmedetomidine, decreases postoperative emergence agitation after strabismus surgery compared to placebo


Secondary Outcome Measures:
  • Post operative interventions [ Time Frame: 4 hours after surgery ] [ Designated as safety issue: No ]
    to determine whether treatment has any effect on postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU discharge


Estimated Enrollment: 132
Study Start Date: March 2012
Estimated Study Completion Date: October 2014
Estimated 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. 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

Contacts
Contact: Lola Franco, BA 212.263.0531 lola.franco@nyumc.org
Contact: Annelise E von Bergen Granell, BS, MS 212.263.0667 annelise.vonbergengranell@nyumc.org

Locations
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Sub-Investigator: Jason Brown, MD         
Sub-Investigator: Gordana Stjepanovic, MD         
Sub-Investigator: Mark Steele, MD         
Sub-Investigator: Jennifer McGrath, BA, MS         
Sub-Investigator: Lola Franco, BA         
Sub-Investigator: Annelise E von Bergen Granell, BS, MS         
Sub-Investigator: Avri Bohm, BA         
Sub-Investigator: Sorosch Didehvar, MD         
Sub-Investigator: Manit Roy, BS         
Sub-Investigator: Michael Haile, MD         
Principal Investigator: Wanda Chin, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Jason Brown, MD NYU School of Medicine
  More Information

No publications provided

Responsible Party: Wanda Chin, Assistant Professor, 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
Last Updated: March 26, 2014
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:
Strabismus
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on October 19, 2014