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

NCT01901588 | Completed Phase 4 Results

• 1 other identifier: S12-00556
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Strabismus; Delirium on Emergence; Pediatric Disorders

Keywords

strabismus; pediatric; emergence delirium; precedex/dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery

  Length of PACU stay (around 3 hours on average)

Secondary Outcomes (5)

• 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)

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

dexmedetomidine/precedex

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

patients receive saline solution.

Other: Placebo

Interventions

Dexmedetomidine DRUG

intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes

Also known as: Precedex

Dexmedetomidine

Placebo OTHER

intraoperative dose of intravenous placebo

Also known as: saline solution

Placebo

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status of I or II
• male or female, aged 1-7
• has no significant lab abnormalities

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Strabismus; Emergence Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Assistant Professor, Department of Anesthesiology, Perioperative Care, and Pain Medicine
• Organization: NYU School of Medicine

wanda.chin@nyumc.org

212.263.5072

Study Officials

• Jason Brown, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: July 17, 2013
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2016
• Last Updated: July 11, 2016
• Results First Posted: March 8, 2016

Record last verified: 2016-06

Locations

US (1)