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

Psychomotor Agitation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Physical status classification of American Society of Anesthesiologist 1-2, - Healthy, normal - 2-6 years old - Elective operation Exclusion Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Psychomotor Agitation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DexmedetomidineThere 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.

Drug:0.9% Normal SalinePlacebo,Normal saline 10ml ivs. for 10min.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Dexmedetomidine0.25dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min.

Dexmedetomidine0.5dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min.

Dexmedetomidine1.0dexmedetomidine 1 microg.kg(-1) ivs. for 10min.

NormalSalineNormal saline 10ml ivs. for 10min.

Study Status

Unknown status

Start Date: January 2012

Completed Date: April 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Agitation score

Secondary Outcome: Oculomotor reflex

Study sponsors, principal investigator, and references

Principal Investigator: AhYoung Oh

Lead Sponsor: Seoul National University Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01578161

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