Comparison of Esketamine and Sevoflurane on Emergence Agitation
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Group E 1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 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. |
Drug: Esketamine
0.5 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery
Other Names:
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Active Comparator: Group S 1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 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. |
Drug: Sevoflurane
5% sevoflurane for induction and 3-4% sevoflurane for maintain
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- 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.
- the incidence of respiratory depression [during the surgery]
decreased tidal volume or weak chest undulation
- the incidence of desaturation [during the surgery]
the incidence of oxygen saturation below 95% caused by anesthetic agents
- intraocular pressure [the time after intubation and topical anesthesia within 1 minute]
intraocular pressure after induction
- respiration rate [1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation]
respiration rate
- mean blood pressure [1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation]
mean blood pressure
- heart rate [1minutes before induction;1minutes after 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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American Society of Anesthesiologists physical status 1-2
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required to remove the stitches by microscope after corneal surgeries
Exclusion Criteria:
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psychiatric disorders
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cardiovascular disorders
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glaucoma
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contraindications to nasal intubation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University | Shanghai | Shanghai | China | 200031 |
Sponsors and Collaborators
- Eye & ENT Hospital of Fudan University
Investigators
- Principal Investigator: Fang Tan, Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
- Cravero J, Surgenor S, Whalen K. Emergence agitation in paediatric patients after sevoflurane anaesthesia and no surgery: a comparison with halothane. Paediatr Anaesth. 2000;10(4):419-24.
- 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.
- Liao R, Li JY, Liu GY. Comparison of sevoflurane volatile induction/maintenance anaesthesia and propofol-remifentanil total intravenous anaesthesia for rigid bronchoscopy under spontaneous breathing for tracheal/bronchial foreign body removal in children. Eur J Anaesthesiol. 2010 Nov;27(11):930-4. doi: 10.1097/EJA.0b013e32833d69ad.
- 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.
- Welborn LG, Hannallah RS, Norden JM, Ruttimann UE, Callan CM. Comparison of emergence and recovery characteristics of sevoflurane, desflurane, and halothane in pediatric ambulatory patients. Anesth Analg. 1996 Nov;83(5):917-20.
- White PF, Schüttler J, Shafer A, Stanski DR, Horai Y, Trevor AJ. Comparative pharmacology of the ketamine isomers. Studies in volunteers. Br J Anaesth. 1985 Feb;57(2):197-203.
- EA and esketamine