Comparison of the Sedation Effect of Esketamine and Sevoflurane for Pediatric Ophthalmological Procedure
- Registration Number
- NCT05321160
- Lead Sponsor
- Eye & ENT Hospital of Fudan University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- American Society of Anesthesiologists physical status 1-2
- required to remove the stitches by microscope after corneal surgeries
- psychiatric disorders
- cardiovascular disorders
- glaucoma
- contraindications to nasal intubation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group E Esketamine 1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 0.25mg·kg-1 esketamine was administered by vein in one minute, and 0.25mg·kg-1 esketamine was given at the beginning of the surgery. Group S Sevoflurane 1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 4% sevoflurane(FIO2=100%, 3L·min-1) was used to induce anesthesia by mask inhalation and 2-4 % sevoflurane (adjusted according to the depth of the anaesthesia,FIO2=100%, 2L·min-1) was maintained.
- Primary Outcome Measures
Name Time Method the incidence of desaturation duration from the time patient received induction to the time of leaving to the ward, average 1 hour the incidence of oxygen saturation below 95% caused by anesthetic agent.
the incidence of hypotension duration from the time patient received induction to the end of the anesthesia, average 15 minutes. the incidence of systolic blood pressure\< 30% of basal systolic blood pressure and lasted \>5 minutes.
the incidence of respiratory depression duration from the time patient received induction to the time of leaving to the ward, average 1 hour respiratory rate \<12 times per min or weak chest undulation
the incidence of hypertension duration from the time patient received induction to the end of the anesthesia, average 15 minutes. the incidence of systolic blood pressure \> 30% of basal systolic blood pressure
the incidence of emergence agitation duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes the incidence of emergence agitation
the incidence of tachycardia duration from the time patient received induction to the end of the anesthesia, average 15 minutes. the incidence of heart rate increase over 30% of pre-induction and\>120 beats per minute.
the incidence of bradycardia duration from the time patient received induction to the end of the anesthesia, average 15 minutes. the incidence of heart rate less than 60 beats per minute
- Secondary Outcome Measures
Name Time Method diastolic pressure 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation diastolic pressure
intraocular pressure the time after intubation and topical anesthesia within 1 minute intraocular pressure after induction
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 minutes the time of patients staying in post-anesthesia care unit
CPS score scores at the time point of 1 minutes after extubation 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.
systolic pressure 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation systolic pressure
heart rate 1minutes before induction; 1minutes before intubation;1minutes after intubation,3 minutes after intubation heart rate
extubation time duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minutes extubation time
Trial Locations
- Locations (1)
Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China