Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02244515
Recruitment Status : Unknown
Verified September 2014 by Jin Ni, Guangzhou Women and Children's Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : September 19, 2014
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
Jin Ni, Guangzhou Women and Children's Medical Center

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.

Condition or disease Intervention/treatment Phase
Emergence Deliruim; Cerebral Palsy Drug: dexmedetomidine Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy
Study Start Date : June 2014
Actual Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine


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%




Primary Outcome Measures :
  1. pediatric anesthesia emergence delirium (PAED) scale [ Time Frame: during stay in postanesthesia care unit ]
  2. Heart rate [ Time Frame: during surgical procedures ]
  3. systolic blood pressure [ Time Frame: during surgical procedures ]
  4. diastolic blood pressure [ Time Frame: during surgical procedures ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Layout table for additonal information
Responsible Party: Jin Ni, Vice-administrator of Department of Anesthesiology, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT02244515     History of Changes
Other Study ID Numbers: ED cerebral palsy
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by Jin Ni, Guangzhou Women and Children's Medical Center:
children
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Dexmedetomidine
Sevoflurane
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General