Psychomotor Agitation
Conditions
Keywords
child, ketamine, midazolam
Brief summary
Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia
Detailed 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.
Interventions
DRUGMidazolam
preoperatively injected intravenous 0.1 mg/kg midazolam
DRUGKetamine
Preoperatively injected intravenous 1mg/kg ketamine
Sponsors
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence Agitation | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| 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 | 33 |
| Total | 67 |
Baseline characteristics
| Characteristic | Midazolam | Ketamine | Total |
|---|---|---|---|
| Age, Continuous | 4.15 year STANDARD_DEVIATION 1.4 | 4.21 year STANDARD_DEVIATION 1.32 | 4.18 year STANDARD_DEVIATION 1.35 |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
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.
Time frame: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Midazolam | Emergence Agitation | 6 participants |
| Ketamine | Emergence Agitation | 0 participants |