Entropion
Conditions
Keywords
Anesthesia, Agitation, Extubation
Brief summary
The investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery.
Detailed description
This study will compare the extubation time and recovery profiles (degree of postoperative agitation and cough) between sevoflurane group and desflurane group. General anesthesia will maintained with sevoflurane 2-3vol% or desflurane 6-7vol%. After surgery, the investigators will measure the duration of extubation and recovery profiles between two groups.
Interventions
DRUGSevoflurane
Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with sevoflurane 2-3 vol%.
DRUGDesflurane
Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.
Sponsors
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* American society of anesthesiologist class 1 patients * 3-6 years children undergoing entropion surgery
Exclusion criteria
* Do not agree with participate this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation Time | 30 minutes | compare the extubation time between sevoflurane and desflurane group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Postoperative Agitation | 30 minutes | Postoperative agitation will measure using Pediatric Anesthesia Emergence Delirium (PAED) scale. PAED scale is (1) The child makes eye contact with the caregiver (2) The child's action are purposeful (3) The child is aware of his/her surrounding (4) The child is restless (5) The child is inconsolable. It scores 0-4, and total maximum score is 20. PAED score \> 12 was used to determine occurence of postoperative agitation. |
Countries
South Korea
Participant flow
Pre-assignment details
A total of 56 patients were enrolled in this study and no patient was dropped.
Participants by arm
| Arm | Count |
|---|---|
| Sevoflurane Group The patients will maintained general anesthesia with sevoflurane.
Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.
General anesthesia will maintained with sevoflurane 2-3 vol%. | 28 |
| Desflurane Group The patients will maintained general anesthesia with desflurane.
Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.
General anesthesia will maintained with desflurane 6-7vol%. | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Sevoflurane Group | Desflurane Group | Total |
|---|---|---|---|
| Age, Continuous | 4.3 years STANDARD_DEVIATION 1.1 | 4.6 years STANDARD_DEVIATION 1.1 | 4.5 years STANDARD_DEVIATION 1.1 |
| Height | 107.8 centimeter STANDARD_DEVIATION 7.4 | 108.6 centimeter STANDARD_DEVIATION 9.9 | 108.2 centimeter STANDARD_DEVIATION 8.722 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 28 Participants | 28 Participants | 56 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Korea | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 5 / 28 | 1 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Extubation Time
compare the extubation time between sevoflurane and desflurane group
Time frame: 30 minutes
Population: A total of 56 patients were enrolled in this study and no patient was dropped.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sevoflurane Group | Extubation Time | 756.3 seconds | Standard Deviation 267.2 |
| Desflurane Group | Extubation Time | 425.9 seconds | Standard Deviation 122.9 |
Secondary
Degree of Postoperative Agitation
Postoperative agitation will measure using Pediatric Anesthesia Emergence Delirium (PAED) scale. PAED scale is (1) The child makes eye contact with the caregiver (2) The child's action are purposeful (3) The child is aware of his/her surrounding (4) The child is restless (5) The child is inconsolable. It scores 0-4, and total maximum score is 20. PAED score \> 12 was used to determine occurence of postoperative agitation.
Time frame: 30 minutes
Population: A total of 56 patients were enrolled in this study and no patient was dropped.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sevoflurane Group | Degree of Postoperative Agitation | 15 units on a scale |
| Desflurane Group | Degree of Postoperative Agitation | 10 units on a scale |