Comparison of the Sedation Effect of Esketamine and Sevoflurane for Pediatric Ophthalmological Procedure

Adverse Event Clinical Trial

Official title:

Comparison of Esketamine Versus Sevoflurane Add to Dexmedetomidine-based Sedation for Minor Ophthalmology Procedure in Children: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05321160
• Other study ID #: EA and esketamine
• Status: Completed
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: May 17, 2023

Study information

• Verified date: March 2024
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 17, 2023
• Est. primary completion date: May 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Event

Intervention

Drug:
• Esketamine
0.25 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery
• Sevoflurane
4% sevoflurane for induction and 2-4% sevoflurane for maintain

Locations

Country	Name	City	State
China	Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. doi: 10.1046/j.1460-9592.2000.00560.x. — View Citation

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. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1097/00000539-199611000-00005. — View Citation

White PF, Schuttler 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. doi: 10.1093/bja/57.2.197. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of respiratory depression	respiratory rate <12 times per min or weak chest undulation	duration from the time patient received induction to the time of leaving to the ward, average 1 hour
Primary	the incidence of desaturation	the incidence of oxygen saturation below 95% caused by anesthetic agent.	duration from the time patient received induction to the time of leaving to the ward, average 1 hour
Primary	the incidence of hypotension	the incidence of systolic blood pressure< 30% of basal systolic blood pressure and lasted >5 minutes.	duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
Primary	the incidence of hypertension	the incidence of systolic blood pressure > 30% of basal systolic blood pressure	duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
Primary	the incidence of tachycardia	the incidence of heart rate increase over 30% of pre-induction and>120 beats per minute.	duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
Primary	the incidence of bradycardia	the incidence of heart rate less than 60 beats per minute	duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
Primary	the incidence of emergence agitation	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
Secondary	length of stay in the post-anesthesia care unit	the time of patients staying in 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
Secondary	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
Secondary	intraocular pressure	intraocular pressure after induction	the time after intubation and topical anesthesia within 1 minute
Secondary	diastolic pressure	diastolic pressure	1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation
Secondary	systolic pressure	systolic pressure	1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation
Secondary	heart rate	heart rate	1minutes before induction; 1minutes before intubation;1minutes after intubation,3 minutes after intubation
Secondary	extubation time	extubation time	duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minutes