An observational study in Ophthalmic Abnormalities and Pediatric Disorder, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Pusan National University Yangsan Hospital · Observational
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.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's enrollment of 146 is close to the median of 153 across 446 observational studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.
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Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia
Exclusion Criteria:
general anesthesia with remimazolam in pediatric patients undergoing ophthalmic surgery
Time to extubation
Time to extubation after the end of general anesthesia
Time frame: Immediate after the end of general anesthesia
Time for post-anesthesia recovery
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: 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
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
Incidence of emergence delirium
Emergence delirium measured after entering the PACU
Time frame: Immediate after entering the PACU, 15 minutes after entering the PACU
Adverse events and complications
Adverse events and complications that occur during anesthesia and recovery from anesthesia
Time frame: during general anesthesia, and recovery after general anesthesia, up to 1 day
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Pusan National University Yangsan Hospital