NCT02244515

Brief Summary

The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Status
unknown

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

June 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

3 months

First QC Date

September 17, 2014

Last Update Submit

September 18, 2014

Conditions

Emergence Deliruim; Cerebral Palsy

Keywords

children

Outcome Measures

Primary Outcomes (4)

  • pediatric anesthesia emergence delirium (PAED) scale

    during stay in postanesthesia care unit

  • Heart rate

    during surgical procedures

  • systolic blood pressure

    during surgical procedures

  • diastolic blood pressure

    during surgical procedures

Study Arms (2)

Group C

PLACEBO COMPARATOR

Five minutes prior to the commencement of the surgical procedure, Group D participants were administered 10 ml NaCI 0.9%.

Group D

EXPERIMENTAL

Five minutes prior to the commencement of the surgical procedure, Group D participants were administered dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%

Drug: dexmedetomidine

Interventions

dexmedetomidineDRUG

dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%

Group D

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Non-quadriplegic (mono-,di-, hemiplegic) children with CP that are scheduled for elective Achilles-tendon lengthening procedure Guangzhou Women and Children's Medical Center, Guangzhou, China, with American Society of Anesthesiologists (ASA) physical status I or II.

You may not qualify if:

  • Participants that displayed symptoms of sinus bradycardia and atrio-ventricular block, non-communicative severe developmental delay, seizure disorders, and treatment with seizure medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice-administrator of Department of Anesthesiology

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 19, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2014

Last Updated

September 19, 2014

Record last verified: 2014-09