drugset / Trial / NCT05011214

Comparison of Sedation by Esketamine and Sevoflurane

NCT05011214

Phase 4 Unknown 60 enrolled Eye & ENT Hospital of Fudan University
RandomizedParallel-groupTriple-blindSupportive care

Summary

Pediatric diseases,including congenital cataract,,corneal injury,corneal ulcer, usually need suture removal and ophthalmic examination after Surgery for several days. Unfortunately, it remains a great challenge to achieve successful sedation due to children's noncooperation. Sevoflurane is one of the most often used anesthesia agents to provide deep sedation. Although sevoflurane has been used for pediatric anesthesia with successful keep spontaneous breathing without intubation, it should be noted that sevoflurane often results in air pollution under the open airway background and postoperative agitation. Esketamine is the S (+) isomer of ketamine, which produces a dissociated state with minimal risk of airway compromise or apnea. It has enhanced analgesic potency and faster elimination compared to ketamine. However, it may also cause delirium during the recovery time. Based on these experiences on ketamine, we compared the effectiveness of esketamine and sevoflurane for short ophthalmological procedure in pediatric patients.

Timeline

Start
2021-09-20
Primary completion
2021-12-31
Completion
2022-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 0.5 mg/kg Intravenous
Comparator Sevoflurane Other / unclassified 3 % Inhaled

Indications

No indication recorded.