The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06035757
• Other study ID #: KUMC2023-05-082
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 15, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: September 2023
• Source: Konkuk University Medical Center
• Contact: Yea-Ji Lee, M.D Ph. D
• Phone: +82-2-2030-5450
• Email: ladydaisy82[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Delirium
• Pediatric ALL
• Strabismus

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-min intervals from the end of anesthesia to dischrage from PACU.