Pusan National University Yangsan Hospital
Yangsan, South Korea
NCT Number: NCT06053489
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.
Looking for future studies?
Notify Me3 year–18 year
All sexes
Observational
Yangsan, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
general anesthesia with remimazolam in pediatric patients undergoing ophthalmic surgery
Time frame: Immediate after the end of general anesthesia
Time to extubation after the end of general anesthesia
Time frame: 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
Time taken until the patient can leave the PACU. The post-anesthesia recovery score (modified Aldrete score) is used for assessment of patient's activity, respiration, blood pressure, consciousness, and peripheral oxygen saturation. A score 9 points or more is required for discharge from the PACU.
Time frame: Immediate after entering the PACU, 15 minutes after entering the PACU
Visual analog scale (VAS) is going to be measured after entering the PACU. The VAS is a validated, subjective measure for acute and chronic pain. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Time frame: Immediate after entering the PACU, 15 minutes after entering the PACU
Emergence delirium measured after entering the PACU
Time frame: during general anesthesia, and recovery after general anesthesia, up to 1 day
Adverse events and complications that occur during anesthesia and recovery from anesthesia
Pusan National University Yangsan Hospital
Other
Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients Who Underwent Ophthalmic Surgery Under General Anesthesia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05848336
Autism Spectrum Disorder, Child Development Disorders, Pervasive
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06489951
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Chongqing, Chongqing Municipality, China
View Trial DetailsNCT05590884
Body Indication, Central Nervous System Diseases
Cincinnati, Ohio, United States
View Trial DetailsNCT05762835
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Infant, Newborn, Diseases
Sacramento, California, United States
View Trial Details