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Completed

NCT Number: NCT02256358

Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia

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Key information

Conditions

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

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (<2hr)

Exclusion criteria

  • children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection

Treatment and study plan

midazolam

Drug

preoperatively injected intravenous 0.1 mg/kg midazolam

ketamine

Drug

Preoperatively injected intravenous 1mg/kg ketamine

Other names: Ketamine HCl

Primary outcomes

  1. Emergence Agitation

    Time frame: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes

    The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 3, 2014
Registry last updated
Oct 20, 2014

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.

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