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The present trial conducted to demonstrate the administration of sugammadex as reversal of neuromuscular blockade agent reduces the incidence of emergence agitation (EA) comparing to neostigmine
EA is one of the most common postoperative complications in after general anesthesia in pre-school aged pediatric patients. There are several causes contributed to occurrence of EA such as postoperative pain, type of surgery and surgical site, hyperthermia or hypothermia. Some researches showed that the occurrence of EA is associated with patients' anxiety and investigators of this trial inferred that patients' anxiety after general anesthesia could be related to ability to breathe. Ability to breathe is highly associated with level of residual neuromuscular blockade (NMB) after recovery from general anesthesia. Investigators evaluate the Pediatric Anesthesia Emergence Delirium (PAED) Scale to investigate whether sugammadex as reversal agents of NMB reduces the incidence of EA in pediatric patients who undergo strabismus surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group pyridostigmine | Active Comparator | If TOF count is 1 or less, wait until it becomes 2 and then give the patient pyridostigmine dose of 350mcg/kg. If TOF count shows 4 with fade, 350mcg/kg of pyridostigmine is administered and without fade, 200mcg/kg is administered. |
|
| group sugammadex | Active Comparator | If TOF count shows 0 and PTC (posttetanic count) is 1 or more, sugammadex administered dose of 4mg/kg. If TOF count shows 1 or more, 2mg/kg is administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bridion 200 MG in 2 ML Injection | Drug | Sugammadex is administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each reversal agent is determined with response to TOF or PTC. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of EA in postanesthesia care unit (PACU) | EA is assessed with the PAED scale in PACU. EA is defined as the score is 10 or higher. | EA is assessed three times at 15-minute intervals in PACU until discharge from PACU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yea-Ji Lee, M.D Ph. D | Contact | +82-2-2030-5450 | ladydaisy82@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Yea-Ji Lee, M.D Ph. D | Konkuk University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Recruiting | Seoul | Seoul-T'ǔkpyǒlshi | 05030 | South Korea |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D013285 | Strabismus |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D007267 | Injections |
| D011729 | Pyridostigmine Bromide |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| Pyridostigmine Bromide 5 MG/ML | Drug | Pyridostigmine is administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each reversal agent is determined with response to TOF. |
|
|
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |