Clinical trial NCT05011214: Comparison of Sedation by Esketamine and Sevoflurane
Official title: Comparison of Sedation by Esketamine and Sevoflurane for Short Ophthalmological Procedure in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sevoflurane
Keywords: esketamine
sevoflurane
sedation
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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 to avoid body movement and keep perfect eye position due to children's noncooperation. Thus, appropriate sedative agents therefore need to be administrated to perform this minor surgery. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been used for successful keeping spontaneous breathing without tracheal intubation. It should be noted that sevoflurane often results in air pollution under the open airway background and emergence agitation. High concentrations of sevoflurane may causes respiratory depression due to the decrease in tidal volume during spontaneous ventilation.

Ketamine is widely used for procedural sedation, which produces a dissociated state with minimal risk of airway compromise or apnea. Esketamine is the S (+) isomer of ketamine, It has enhanced analgesic potency and faster elimination compared to ketamine. However, it may also cause agitation 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.

Eligibility criteria: Inclusion Criteria:

* patient who needed suture removal and ophthalmic examination

Exclusion Criteria:

* previous coronary heart disease,hypertension, arterial aneurysm, epilepsia, intracranial mass of benign or malign nature

Primary outcomes:
measure: eye position scale
timeFrame: during the surgery
Secondary outcomes:
measure: the incidence of respiratory depression
timeFrame: during the surgery
measure: the incidence of desaturation
timeFrame: during the surgery
measure: Intraocular pressure
timeFrame: the time after intubation and topical anesthesia within 1 minute
measure: requirements for additional propofol
timeFrame: during the surgery
measure: CPS score
timeFrame: scores at the time point of 1 minutes after extubation
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 mins
measure: Mean blood pressure pressure
timeFrame: 1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation
measure: Heart rate
timeFrame: 1minutes before induction;1minutes after induction;1minutes before extubation;1minutes after extubation,3 minutes after extubation
measure: extubation time
timeFrame: duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 mins
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:
citation: Green SM, Roback MG, Kennedy RM, Krauss B. Clinical practice guideline for emergency department ketamine dissociative sedation: 2011 update. Ann Emerg Med. 2011 May;57(5):449-61. doi: 10.1016/j.annemergmed.2010.11.030. Epub 2011 Jan 21.
citation: Cao Q, Lin Y, Xie Z, Shen W, Chen Y, Gan X, Liu Y. Comparison of sedation by intranasal dexmedetomidine and oral chloral hydrate for pediatric ophthalmic examination. Paediatr Anaesth. 2017 Jun;27(6):629-636. doi: 10.1111/pan.13148. Epub 2017 Apr 17.
citation: Krishnappa S, Kundra P. Optimal anaesthetic depth for LMA insertion. Indian J Anaesth. 2011 Sep;55(5):504-7. doi: 10.4103/0019-5049.89887.