The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

Sponsor

Konkuk University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06035757

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The present tiral conduted to demonstrate the administration of sugammadex as reversal of neuromuscular blockade agent reduces the incedence of emergence agitation (EA) comparing to neostigmine

Condition or Disease	Intervention/Treatment	Phase
Emergence Delirium Strabismus Pediatric ALL	Drug: Bridion 200 MG in 2 ML Injection Drug: Neostigmine Methylsulfate	Phase 4

Detailed Description

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 we 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. We 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Aug 15, 2024

Anticipated Study Completion Date :

Aug 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group neostigmine If TOF count is 1 or less, wait until it becomes 2 and then give the patient neostigmine dose of 50mcg/kg. If TOF count shows 4 with fade, 40mcg/kg of neostigmine is administered and without fade, 20mcg/kg is administered.	Drug: Neostigmine Methylsulfate Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC. Other Names: neostigmine
Active Comparator: group sugammadex If TOF count shows 0 and PTC (posttetanic count) is 1 or more, sugamadex administered dose of 4mg/kg. If TOF count shows 1 or more, 2mg/kg is administered.	Drug: Bridion 200 MG in 2 ML Injection Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC. Other Names: Bridion

Arm

Intervention/Treatment

Active Comparator: group neostigmine

If TOF count is 1 or less, wait until it becomes 2 and then give the patient neostigmine dose of 50mcg/kg. If TOF count shows 4 with fade, 40mcg/kg of neostigmine is administered and without fade, 20mcg/kg is administered.

Drug: Neostigmine Methylsulfate

Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC.

Other Names:

neostigmine

Active Comparator: group sugammadex

If TOF count shows 0 and PTC (posttetanic count) is 1 or more, sugamadex administered dose of 4mg/kg. If TOF count shows 1 or more, 2mg/kg is administered.

Drug: Bridion 200 MG in 2 ML Injection

Other Names:

Bridion

Outcome Measures

Primary Outcome Measures

The incidence of EA in postanesthesia care unit (PACU) [EA is assessed three times at 15-min intervals from the end of anesthesia to dischrage from PACU.]
EA is assessed with the PAED scale in PACU. EA is defined as the score is 10 or higher.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Pateints scheduled elective stramismus surgery aged 4-7 with American Society of Anesthesiologists (ASA) classification 1-3.

Exclusion Criteria:

ASA classification 3 or more
impaired liver function
impaired kidney function
myasthenia gravis or other neuromuscular disorders
history of drug allergy
cardiovascular disease or arryrhthmia

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Konkuk University Medical Center

Investigators

Principal Investigator: Yea-Ji Lee, M.D Ph. D, Konkuk University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yea-Ji Lee, Assisstant professor, Konkuk University Medical Center

ClinicalTrials.gov Identifier:

NCT06035757

Other Study ID Numbers:

KUMC2023-05-082

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Strabismus

Emergence Delirium

Neostigmine

Study Results

No Results Posted as of Sep 13, 2023