NCT01528891

Brief Summary

To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2012

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 25, 2015

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

2.6 years

First QC Date

February 6, 2012

Results QC Date

September 16, 2015

Last Update Submit

March 6, 2018

Conditions

Tonsillectomy

Keywords

tonsillectomyemergence agitation

Outcome Measures

Primary Outcomes (3)

  • Heart Rate (HR)

    beats per minute (bpm)

    Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).

  • Systolic Blood Pressure (SBP)

    mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.

    Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).

  • Diastolic Blood Pressure (DBP)

    mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.

    Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).

Secondary Outcomes (1)

  • Incidence of Emergence Agitation (EA)

    The highest PAED score for each patient within the first 30 minutes after waking up was recorded.

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine

Drug: Dexmedetomidine

placebo

PLACEBO COMPARATOR

Normal saline

Other: Placebo

Interventions

DexmedetomidineDRUG

0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery

Also known as: Precedex
Dexmedetomidine
PlaceboOTHER
placebo

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
  • ASA 1,2,3
  • females who have started menses but have a negative urine pregnancy test

You may not qualify if:

  • patients with known dysrhythmias,
  • not recovering in the ICU
  • developmental delay,
  • autism communication disorder
  • bleeding disorder
  • PI discretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Peter J. Davis, MD
Organization
Children's Hospital of Pittsburgh of UPMC
davispj@anes.upmc.edu
4126925260

Study Officials

  • Peter J Davis, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist-in-Chief

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 8, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 8, 2018

Results First Posted

November 25, 2015

Record last verified: 2018-03

Locations

US(2)