Comparison of Sedation by Esketamine and Sevoflurane

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Sedation by Esketamine and Sevoflurane for Short Ophthalmological Procedure in Children

Conditions
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Sevoflurane

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Esketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group S<br>patients were anesthetized by face mask with 5 vol% sevoflurane with total 5 L/min-1 fresh gas flow. Anaesthesia was maintained by continuously using 3-4% sevoflurane. | Drug: Sevoflurane<br>* All patients received 0.01 mg/kg atropine and 1ug/kg dexmedetomidine iv as premedication.5% sevoflurane(FIO2=100%, 3L·min-1) was used to induce anaesthesia by mask inhalation and 3-4 % sevoflurane (adjusted according to the depth of the anaesthesia,FIO2=100%, 2L·min-1) was maintained<br>* Other names: Sevoflurane Inhalation Solution;|
| Experimental: group E<br>patients received 0.5mg/kg IV esketamine at first, after surgical field disinfection, another 0.25mg/kg IV esketamine was administered. Then 1mg/kg propofol was administered every 5 minutes after intubation. | Drug: Esketamine<br>* All patients received 0.1 mg/kg atropine and 1ug/kg dexmedetomidine iv as premedication.0.5mg·kg-1 esketamine was administered by vein in one minute, and 0.25mg·kg-1 esketamine was given at the beginning of the surgery.<br>* Other names: s(+)ketamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eye position scale | 1=The inner and outer canthus line across the central cornea; 2= Inferior limbus does not exceed the inner and outer canthus line; 3= Inferior limbus exceed the inner and outer canthus line. | during the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of respiratory depression | decreased tidal volume or weak chest undulation | during the surgery | 
| the incidence of desaturation | the incidence of oxygen saturation below 95% caused by anesthetic agents | during the surgery | 
| Intraocular pressure | Intraocular pressure after induction | the time after intubation and topical anesthesia within 1 minute | 
| requirements for additional propofol | If the target level of sedation was not achieved, an additional 0.1mg/kg propofol was injected and repeated if necessary | during the surgery | 
| CPS score | The Cole 5-point scale (CPS) score included five behaviors: 1=sleeping; 1=awake,calm;3=irritable, crying;4=inconsolable crying; 5=severe restlessness, disorientation. | scores at the time point of 1 minutes after extubation | 
| length of stay in the post-anesthesia care unit | the time of the length of stay in the post-anesthesia care unit | duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 mins | 
| Mean blood pressure pressure | mean blood pressure | 1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation | 
| Heart rate | Heart rate | 1minutes before induction;1minutes after induction;1minutes before extubation;1minutes after extubation,3 minutes after extubation | 
| extubation time | extubation time | duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esketamine, sevoflurane, sedation