Clinical trial NCT06053489: Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients
Official title: Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients Who Underwent Ophthalmic Surgery Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmic Abnormalities
Pediatric Disorder
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 146
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia

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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

- none

Primary outcomes:
measure: Time to extubation
timeFrame: Immediate after the end of general anesthesia
Secondary outcomes:
measure: Time for post-anesthesia recovery
timeFrame: 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
measure: Postoperative pain
timeFrame: Immediate after entering the PACU, 15 minutes after entering the PACU
measure: Incidence of emergence delirium
timeFrame: Immediate after entering the PACU, 15 minutes after entering the PACU
measure: Adverse events and complications
timeFrame: during general anesthesia, and recovery after general anesthesia, up to 1 day
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital, Yangsan, South Korea
name: Hee Young Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: