Adverse Event
Conditions
Keywords
adverse event, sevoflurane, esketamine
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.
Interventions
DRUGEsketamine
0.25 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery
DRUGSevoflurane
4% sevoflurane for induction and 2-4% sevoflurane for maintain
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| intraocular pressure | the time after intubation and topical anesthesia within 1 minute | intraocular pressure after induction |
| diastolic pressure | 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation | diastolic pressure |
| 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 |
Countries
China
Outcome results
None listed