Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation
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|ClinicalTrials.gov Identifier: NCT02256358|
Recruitment Status : Completed
First Posted : October 3, 2014
Results First Posted : October 9, 2014
Last Update Posted : October 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Psychomotor Agitation||Drug: Midazolam Drug: Ketamine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Active Comparator: Midazolam
Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
preoperatively injected intravenous 0.1 mg/kg midazolam
Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Preoperatively injected intravenous 1mg/kg ketamine
Other Name: Ketamine HCl
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256358
|Study Chair:||Kihwa Lee, MD||Haeundae paik hospital, inje university|