Clinical trial NCT05321160: Comparison of the Sedation Effect of Esketamine and Sevoflurane for Pediatric Ophthalmological Procedure
Official title: Comparison of Esketamine Versus Sevoflurane Add to Dexmedetomidine-based Sedation for Minor Ophthalmology Procedure in Children: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Event
Keywords: adverse event
sevoflurane
esketamine
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 116
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Ophthalmological procedure such as suture remove, intraocular pressure (IOP) measurement, slit-lamp and fundoscopy are most frequently performed in operation with minor surgical stimulus, and the the duration of surgery is very short. Several anesthestic agents are available,but it is hard to balance short effect and fast rotation in post-anesthesia care unit. 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. Additionally, several studies have reported ketamine could reduced agitation, but there is no study about esketamine on emergence agitation. The investigators compared the effectiveness of esketamine and sevoflurane in reducing the incidence of emergence agitation after painless ophthalmological procedure in pediatric patients.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status 1-2
* required to remove the stitches by microscope after corneal surgeries

Exclusion Criteria:

* psychiatric disorders
* cardiovascular disorders
* glaucoma
* contraindications to nasal intubation

Primary outcomes:
measure: the incidence of respiratory depression
timeFrame: duration from the time patient received induction to the time of leaving to the ward, average 1 hour
measure: the incidence of desaturation
timeFrame: duration from the time patient received induction to the time of leaving to the ward, average 1 hour
measure: the incidence of hypotension
timeFrame: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
measure: the incidence of hypertension
timeFrame: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
measure: the incidence of tachycardia
timeFrame: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
measure: the incidence of bradycardia
timeFrame: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
measure: the incidence of emergence agitation
timeFrame: duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes
Secondary outcomes:
measure: length of stay in the post-anesthesia care unit
timeFrame: duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes
measure: CPS score
timeFrame: scores at the time point of 1 minutes after extubation
measure: intraocular pressure
timeFrame: the time after intubation and topical anesthesia within 1 minute
measure: diastolic pressure
timeFrame: 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation
measure: systolic pressure
timeFrame: 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation
measure: heart rate
timeFrame: 1minutes before induction; 1minutes before intubation;1minutes after intubation,3 minutes after intubation
measure: extubation time
timeFrame: duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minutes
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
name: Fang Tan
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Patrizi A, Picard N, Simon AJ, Gunner G, Centofante E, Andrews NA, Fagiolini M. Chronic Administration of the N-Methyl-D-Aspartate Receptor Antagonist Ketamine Improves Rett Syndrome Phenotype. Biol Psychiatry. 2016 May 1;79(9):755-764. doi: 10.1016/j.biopsych.2015.08.018. Epub 2015 Aug 24.
citation: Eich C, Verhagen-Henning S, Roessler M, Cremer F, Cremer S, Strack M, Russo SG. Low-dose S-ketamine added to propofol anesthesia for magnetic resonance imaging in children is safe and ensures faster recovery--a prospective evaluation. Paediatr Anaesth. 2011 Feb;21(2):176-8. doi: 10.1111/j.1460-9592.2010.03489.x. No abstract available.