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The investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane Group | Active Comparator | The patients will maintained general anesthesia with sevoflurane. |
|
| Desflurane Group | Experimental | The patients will maintained general anesthesia with desflurane. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with sevoflurane 2-3 vol%. |
| Measure | Description | Time Frame |
|---|---|---|
| Extubation Time | compare the extubation time between sevoflurane and desflurane group | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki Hwa Lee, M.D, | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haeundae paik hospital, inje university | Busan | 612-896 | South Korea |
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A total of 56 patients were enrolled in this study and no patient was dropped.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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%. |
| FG001 | 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%. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 56 patients were enrolled in this study and no patient was dropped.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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%. |
| BG001 | Desflurane Group |
| 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 | Extubation Time | compare the extubation time between sevoflurane and desflurane group | A total of 56 patients were enrolled in this study and no patient was dropped. | Posted | Mean | Standard Deviation | seconds | 30 minutes |
|
30 minutes after surgery
There was no serious adverse event.
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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 | 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%. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| copious secretion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
There was non-ketamine (control) group. We used ketamine for reducing of separation anxiety of children.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ki Hwa Lee | Inje University, Haeundae Paik hospital | 82-51-797-0421 | tedy3333@naver.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2019 | Apr 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004774 | Entropion |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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|
| Desflurane | Drug | Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%. |
|
|
| 30 minutes |
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%. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | centimeter | Mean | Standard Deviation | centimeter |
|
|
|
| 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. | A total of 56 patients were enrolled in this study and no patient was dropped. | Posted | Median | Inter-Quartile Range | units on a scale | 30 minutes |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 5 |
| 28 |
| EG001 | 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%. | 0 | 28 | 0 | 28 | 1 | 28 |
| laryngospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D005019 | Ethyl Ethers |