Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy

September 18, 2014 updated by: Jin Ni
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group C
Five minutes prior to the commencement of the surgical procedure, Group D participants were administered 10 ml NaCI 0.9%.
Experimental: Group D
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
dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pediatric anesthesia emergence delirium (PAED) scale
Time Frame: during stay in postanesthesia care unit
during stay in postanesthesia care unit
Heart rate
Time Frame: during surgical procedures
during surgical procedures
systolic blood pressure
Time Frame: during surgical procedures
during surgical procedures
diastolic blood pressure
Time Frame: during surgical procedures
during surgical procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jin Ni

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED cerebral palsy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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