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

NCT01578161 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2012-04-16

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

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.

DRUG

0.9% Normal Saline

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

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • AhYoung Oh · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-01-31
Completion
2013-04-30

Countries

  • South Korea

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01578161 on ClinicalTrials.gov