CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 116 enrolled
Drug / intervention
Esketamine +1 moredrug
Likely dose
Esketamine 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05321160
NCT05321160N/ACompleted

Comparison of Esketamine Versus Sevoflurane Add to Dexmedetomidine-based Sedation for Minor Ophthalmology Procedure in Children: A Randomized Controlled Trial.

Eye & ENT Hospital of Fudan University·interventional·Posted Apr 11, 2022·Updated Mar 26, 2024

In Brief

A clinical study evaluating Esketamine and Sevoflurane for Adverse Event. Completed, enrolled 116 participants across 1 site.

Detailed Summary

Emergence agitation is the most common reason for post-anesthesia care unit delay. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been successfully used for keeping spontaneous breathing without tracheal intubation. However, sevoflurane may cause emergence agitation as the incidence varied from 10%-80%. Although there are many sedative agents to reduce its incidence, such as propofol, midazolam, a2 adrenergic receptor agonists and ketamine, the efficacy remains limited. Ketamine, a neuroleptic anesthetic agent, contains two optical isomers, s(+)-ketamine (esketamine) and R(-)-ketamine. Esketamine is a right-handed split of ketamine, which has enhanced analgesic potency and lower incidence of psychotropic side effects compared to ketamine. It stimulate breathing due to N-Methyl-D-Aspartate receptor blockade, and could even effectively countered remifentanil-induced respiratory depression. The investigators compared the effectiveness of esketamine and sevoflurane in reducing the incidence of emergence agitation after painless ophthalmological procedure in pediatric patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdverse Event
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 11, 2022
Enrollment StartMar 28, 2022
Primary CompletionMay 14, 2023
Study CompletionMay 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.2 years ago

Interventions

Esketaminedrug

0.25 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery

Sevofluranedrug

4% sevoflurane for induction and 2-4% sevoflurane for maintain