Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

Psychomotor Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256358
• Other study ID #: 2012-127
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: October 9, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: October 2014
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Psychomotor Agitation

Intervention

Drug:
• Midazolam
preoperatively injected intravenous 0.1 mg/kg midazolam
• Ketamine
Preoperatively injected intravenous 1mg/kg ketamine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence Agitation	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.	During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes	No