The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia

NCT01578161 | Unknown Phase 4

• 1 other identifier: SNUBH_01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for prevention of agiation of preschool aged children. The investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.

Conditions

Psychomotor Agitation

Outcome Measures

Primary Outcomes (1)

• Agitation score

  30 mins after operation

Secondary Outcomes (1)

• Oculomotor reflex

  Intraoperative

Study Arms (4)

Dexmedetomidine0.25

EXPERIMENTAL

dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min.

Drug: Dexmedetomidine

Dexmedetomidine0.5

EXPERIMENTAL

dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min.

Drug: Dexmedetomidine

Dexmedetomidine1.0

EXPERIMENTAL

dexmedetomidine 1 microg.kg(-1) ivs. for 10min.

Drug: Dexmedetomidine

NormalSaline

PLACEBO COMPARATOR

Normal saline 10ml ivs. for 10min.

Drug: 0.9% Normal Saline

Interventions

Dexmedetomidine DRUG

There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

Also known as: Precedex

Dexmedetomidine0.25; Dexmedetomidine0.5; Dexmedetomidine1.0

0.9% Normal Saline DRUG

Placebo,Normal saline 10ml ivs. for 10min.

NormalSaline

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Physical status classification of American Society of Anesthesiologist 1-2,
• Healthy, normal
• years old
• Elective operation

You may not qualify if:

• Lack of consent
• Known adverse effects to dexmedetomidine, mental retardation
• Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc)
• No cardiac disease

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL

SungNam-si, Kyonggi Do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• AhYoung Oh

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

INAE SONG

CONTACT

82-10-2609-2401; nodame1@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 16, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 16, 2012

Record last verified: 2012-04

Locations

KR (1)