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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
Sponsor:
Information provided by (Responsible Party):
Ki Hwa Lee, Inje University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Psychomotor Agitation
Interventions Drug: Midazolam
Drug: Ketamine
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Midazolam Ketamine
Hide Arm/Group Description

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

Midazolam: 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.

Ketamine: Preoperatively injected intravenous 1mg/kg ketamine

Period Title: Overall Study
Started 34 34
Completed 34 33
Not Completed 0 1
Arm/Group Title Midazolam Ketamine Total
Hide Arm/Group Description

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

Midazolam: 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.

Ketamine: Preoperatively injected intravenous 1mg/kg ketamine

Total of all reporting groups
Overall Number of Baseline Participants 34 33 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 34 participants 33 participants 67 participants
4.15  (1.40) 4.21  (1.32) 4.18  (1.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
Female
18
  52.9%
17
  51.5%
35
  52.2%
Male
16
  47.1%
16
  48.5%
32
  47.8%
1.Primary Outcome
Title Emergence Agitation
Hide Description 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.
Time Frame During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Midazolam Ketamine
Hide Arm/Group Description:

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

Midazolam: 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.

Ketamine: Preoperatively injected intravenous 1mg/kg ketamine

Overall Number of Participants Analyzed 34 33
Measure Type: Number
Unit of Measure: participants
6 0
Time Frame 1 day
Adverse Event Reporting Description Recording of complications at 5 minutes intervals during 30 minutes after operation
 
Arm/Group Title Midazolam Ketamine
Hide Arm/Group Description

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

Midazolam: 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.

Ketamine: Preoperatively injected intravenous 1mg/kg ketamine

All-Cause Mortality
Midazolam Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Midazolam Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Midazolam Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kihwa Lee
Organization: Haeundae Paik Hospital, Inje University
Phone: 82-51-797-0426
Responsible Party: Ki Hwa Lee, Inje University
ClinicalTrials.gov Identifier: NCT02256358     History of Changes
Other Study ID Numbers: 2012-127
First Submitted: October 1, 2014
First Posted: October 3, 2014
Results First Submitted: October 6, 2014
Results First Posted: October 9, 2014
Last Update Posted: October 20, 2014