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NCT02244515 Clinical Trial

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

Emergence Deliruim; Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02244515
Other study ID # ED cerebral palsy
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received September 17, 2014
Last updated September 18, 2014
Start date June 2014

Study information
Verified date September 2014
Source Guangzhou Women and Children's Medical Center
Contact n/a
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Guangdong Province
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 80
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 12 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Jin Ni

Outcome
Type Measure Description Time frame Safety issue
Primary pediatric anesthesia emergence delirium (PAED) scale during stay in postanesthesia care unit No
Primary Heart rate during surgical procedures Yes
Primary systolic blood pressure during surgical procedures Yes
Primary diastolic blood pressure during surgical procedures Yes