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Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Active Comparator | Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room. |
|
| Ketamine | Experimental | Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | preoperatively injected intravenous 0.1 mg/kg midazolam |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kihwa Lee, MD | Haeundae paik hospital, inje university | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam | 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 |
| FG001 | Ketamine | Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room. Ketamine: Preoperatively injected intravenous 1mg/kg ketamine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam | 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 |
| BG001 | Ketamine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes |
|
1 day
Recording of complications at 5 minutes intervals during 30 minutes after operation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Midazolam | 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 |
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We did not include a placebo group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kihwa Lee | Haeundae Paik Hospital, Inje University | 82-51-797-0426 | tedy333@paik.ac.kr |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ketamine |
| Drug |
Preoperatively injected intravenous 1mg/kg ketamine |
|
|
Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Ketamine | Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room. Ketamine: Preoperatively injected intravenous 1mg/kg ketamine | 0 | 34 | 0 | 34 |
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| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006571 | Heterocyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |