Psychomotor Agitation Clinical Trial
Official title:
Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial
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 |
Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Inje University |
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 |
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