Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients

NCT06053489 | Completed

• 1 other identifier: 2023-09-09
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) has a short context-sensitive half-life of 7.5 minutes, and the time it takes from the end of anesthesia until the patient wakes up is predictable. According to a study by Yang X et al., administering a small amount of remimazolam (0.2 mg/kg) intravenously at the end of general anesthesia using sevoflurane reduced the incidence of emergence agitation. However, very few studies have evaluated the use of remimazolam in general anesthesia in pediatric patients.

Conditions

Ophthalmic Abnormalities; Pediatric Disorder

Outcome Measures

Primary Outcomes (1)

• Time to extubation

  Time to extubation after the end of general anesthesia

  Immediate after the end of general anesthesia

Secondary Outcomes (4)

• Time for post-anesthesia recovery

  From the time of immediate after entering the PACU until until achieving post-anesthesia recovery score of 9 or more, assessed up to 4 hours

• Postoperative pain

  Immediate after entering the PACU, 15 minutes after entering the PACU

• Incidence of emergence delirium

  Immediate after entering the PACU, 15 minutes after entering the PACU

• Adverse events and complications

  during general anesthesia, and recovery after general anesthesia, up to 1 day

Interventions

general anesthesia with remimazolam OTHER

general anesthesia with remimazolam in pediatric patients undergoing ophthalmic surgery

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia

You may qualify if:

• Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia
• When anesthesia was induced and maintained with remimazolam, or anesthesia was induced with propofol and maintained with sevoflurane.

You may not qualify if:

• \- none

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Interventions

Anesthesia, General; remimazolam

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Hee Young Kim, MD, PhD

  Pusan National University Yangsan Hospital, Yangsan, South Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor for fund

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: September 25, 2023
• Study Start: July 31, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)