Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients

Pediatric Disorder Clinical Trial

Official title: Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients Who Underwent Ophthalmic Surgery Under General Anesthesia

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

• The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. It has the advantage of being able to induce anesthesia without securing an intravenous route and causing less irritation to the airway. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Emergence agitation can cause physical damage to the patient, workload in the recovery room, and dissatisfaction of the caregiver.

• Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) is a benzodiazepine drug used for inducing and maintaining general anesthesia and for sedation during procedures. When remimazolam is used as a general anesthetic, it has the advantage of being metabolized quickly by enzymes in the liver compared to propofol, has a short context-sensitive half-life of 7.5 minutes, and can be reversed with flumazenil. Therefore, during general anesthesia using remimazolam, 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 and its effect on endotracheal extubation time after anesthesia in operating room, emergence agitation, pain, and discharge time in the postanesthesia care unit (PACU). ;

Related Conditions & MeSH terms

• Congenital Abnormalities
• Pediatric Disorder

• NCT number: NCT06053489
• Study type: Observational
• Source: Pusan National University Yangsan Hospital
• Contact: Hee Young Kim, MD, PhD
• Phone: 82-10-7641-1774
• Email: anekhy@gmail.com
• Status: Not yet recruiting
• Start date: June 30, 2024
• Completion date: December 31, 2024