Skip to main content
OpenTrials
Completed

NCT Number: NCT01512355

The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery

Postoperative agitation in children is a well-documented clinical phenomenon with incidence ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the pediatric population and there is now increasing evidence to support the use of this drug as sedative and anesthetic adjunct in children. The purpose of this study is to determine whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Strabismus Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the patient undergoing the strabismus surgery in severance hospital

Exclusion criteria

  • delayed development
  • mental retardation
  • cerebral palsy
  • preoperative EKG abnormality e.g. cardiovascular conduction disorder

Treatment and study plan

Dexmedetomidine

Drug

After, induction of general anesthesia, dexmedetomidine 0.2 mcg/kg/hr continuous intravenous infused during the surgery

Placebo Group

Drug

normal saline_02mcg/kg/hr

Primary outcomes

  1. objective pain score

    Time frame: immediate postoperative period up to 1hour after surgery

    • Objective pain score(OPS) Blood pressure 0~2 points crying 0~2points movement 0~2points agitation 0~2points posture 0~2points complain of pain(where appropiraate by age) 0~2points total 0~10 points

  2. pediatric anesthesia emergence delirium (PAED) scale

    Time frame: immediate postoperative period up to 1hour after surgery

    • pediatric anesthesia emergence delirium (PAED) scale The Child makes eye contact with the caregiver 0~4 The child's actions are purposeful. 0~4 The child is aware of his'her surroundings. 0~4 The child is restless. 0~4 The child is insonsolable. 0~4 total 0~20 points

  3. 5-point agitation scale

    Time frame: immediate postoperative period up to 1hour after surgery

    • Scoring system for emergence agitation (behavior score)
    • Sleeping
    • Awake and calm
    • Irritable and crying
    • Inconsolable crying
    • Severe restlessness and disorientation

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 19, 2012
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.