Trial Outcomes & Findings for The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing Entropion Surgery (NCT NCT02916407)
NCT ID: NCT02916407
Last Updated: 2019-05-03
Results Overview
compare the extubation time between sevoflurane and desflurane group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
30 minutes
Results posted on
2019-05-03
Participant Flow
A total of 56 patients were enrolled in this study and no patient was dropped.
Participant milestones
| Measure |
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%.
|
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%.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing Entropion Surgery
Baseline characteristics by cohort
| Measure |
Sevoflurane Group
n=28 Participants
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%.
|
Desflurane Group
n=28 Participants
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%.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.3 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
4.6 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
4.5 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Height
|
107.8 centimeter
STANDARD_DEVIATION 7.4 • n=5 Participants
|
108.6 centimeter
STANDARD_DEVIATION 9.9 • n=7 Participants
|
108.2 centimeter
STANDARD_DEVIATION 8.722 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: A total of 56 patients were enrolled in this study and no patient was dropped.
compare the extubation time between sevoflurane and desflurane group
Outcome measures
| Measure |
Sevoflurane Group
n=28 Participants
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%.
|
Desflurane Group
n=28 Participants
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%.
|
|---|---|---|
|
Extubation Time
|
756.3 seconds
Standard Deviation 267.2
|
425.9 seconds
Standard Deviation 122.9
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: A total of 56 patients were enrolled in this study and no patient was dropped.
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.
Outcome measures
| Measure |
Sevoflurane Group
n=28 Participants
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%.
|
Desflurane Group
n=28 Participants
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%.
|
|---|---|---|
|
Degree of Postoperative Agitation
|
15 units on a scale
Interval 6.0 to 20.0
|
10 units on a scale
Interval 5.0 to 20.0
|
Adverse Events
Sevoflurane Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Desflurane Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sevoflurane Group
n=28 participants at risk
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%.
|
Desflurane Group
n=28 participants at risk
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%.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
copious secretion
|
7.1%
2/28 • Number of events 2 • 30 minutes after surgery
There was no serious adverse event.
|
0.00%
0/28 • 30 minutes after surgery
There was no serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
laryngospasm
|
3.6%
1/28 • Number of events 1 • 30 minutes after surgery
There was no serious adverse event.
|
3.6%
1/28 • Number of events 1 • 30 minutes after surgery
There was no serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
desaturation
|
7.1%
2/28 • Number of events 2 • 30 minutes after surgery
There was no serious adverse event.
|
0.00%
0/28 • 30 minutes after surgery
There was no serious adverse event.
|
Additional Information
Dr Ki Hwa Lee
Inje University, Haeundae Paik hospital
Phone: 82-51-797-0421
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place