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

Primary Purpose

Strabismus, Delirium on Emergence, Pediatric Disorders

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dexmedetomidine

Placebo

About this trial

This is an interventional prevention trial for Strabismus focused on measuring strabismus, pediatric, emergence delirium, precedex/dexmedetomidine

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NYU Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine

Placebo

Arm Description

dexmedetomidine/precedex

patients receive saline solution.

Outcomes

Primary Outcome Measures

Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery

Secondary Outcome Measures

Percentage of Participants Receiving Pain Medication

Post-op Pain Interventions

Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications

Time to Arousal

Time to PACU Discharge

Full Information

NCT ID

NCT01901588

First Posted

April 17, 2013

Last Updated

June 8, 2016

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT01901588

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Strabismus, Delirium on Emergence, Pediatric Disorders

Keywords

strabismus, pediatric, emergence delirium, precedex/dexmedetomidine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine

Arm Type

Experimental

Arm Description

dexmedetomidine/precedex

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

patients receive saline solution.

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Precedex

Intervention Description

intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

saline solution

Intervention Description

intraoperative dose of intravenous placebo

Primary Outcome Measure Information:

Title

Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery

Time Frame