Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Psychomotor Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Midazolam

Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

preoperatively injected intravenous 0.1 mg/kg midazolam

Ketamine

Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Preoperatively injected intravenous 1mg/kg ketamine

Interventions

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Midazolam

preoperatively injected intravenous 0.1 mg/kg midazolam

Intervention Type DRUG

Ketamine

Preoperatively injected intravenous 1mg/kg ketamine

Intervention Type DRUG

Other Intervention Names

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Ketamine HCl

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No