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

NCT ID: NCT02244515

Last Updated: 2014-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Emergence Deliruim; Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group C

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

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%

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

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

Interventions

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dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jin Ni

OTHER

Sponsor Role lead

Responsible Party

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Jin Ni

Vice-administrator of Department of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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ED cerebral palsy

Identifier Type: -

Identifier Source: org_study_id

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