Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

Not Applicable

Completed

• Conditions: Psychomotor Agitation
• Interventions: Drug: Ketamine; Drug: Midazolam

• Registration Number: NCT02256358
• Lead Sponsor: Inje University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-10
• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-03
• Results First Submitted: 2014-10-06
• Results First Submitted QC: 2014-10-06
• Results First Posted: 2014-10-09
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Midazolam	Midazolam	Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.

Primary Outcome Measures

Name	Time	Method
Emergence Agitation	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.