Completed

Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery

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What is being tested

Dexmedetomidine

+ normal saline

Drug
Who is being recruted

Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

+ Mobility Limitation

From 1 to 5 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2011
See protocol details

Summary

Principal SponsorYonsei University
Last updated: September 24, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2011

Actual date on which the first participant was enrolled.

Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and anaesthetics that must be concomitantly administered. This study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA in children undergoing ambulatory surgery.

NCT01691001
Principal SponsorYonsei University
Last updated: September 24, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 1 to 5 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsPathological Conditions, Signs and SymptomsMobility Limitation

Criteria

3 inclusion criteria required to participate
ASA class I
aged 1-5 years, and weighing < 20 kg who were undergoing ambulatory hernioplasty or orchiopexy
obtaining written informed consent from the parents
6 exclusion criteria prevent from participating
bilateral procedures
coagulation disorder
developmental delays
mental retardation
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo
normal saline

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Severance Hospital

Seoul, South KoreaOpen Severance Hospital in Google Maps
CompletedOne Study Center