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

NCT05321160 | Completed

• 1 other identifier: EA and esketamine
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Event

Keywords

adverse event; sevoflurane; esketamine

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (7)

• 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

• CPS score

  scores at the time point of 1 minutes after extubation

• intraocular pressure

  the time after intubation and topical anesthesia within 1 minute

• diastolic pressure

  1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation

• systolic pressure

  1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation

Study Arms (2)

Group E

EXPERIMENTAL

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.

Drug: Esketamine

Group S

ACTIVE COMPARATOR

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.

Drug: Sevoflurane

Interventions

Esketamine DRUG

0.25 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery

Also known as: s(+)ketamine

Group E

Sevoflurane DRUG

4% sevoflurane for induction and 2-4% sevoflurane for maintain

Also known as: Sevoflurane Inhalation Solution

Group S

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists physical status 1-2
• required to remove the stitches by microscope after corneal surgeries

You may not qualify if:

• psychiatric disorders
• cardiovascular disorders
• glaucoma
• contraindications to nasal intubation

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (6)

• 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.

  PMID: 20683333 BACKGROUND

• 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.

  PMID: 10886700 BACKGROUND

• 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.

  PMID: 8895263 BACKGROUND

• 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.

  PMID: 3970799 BACKGROUND

• 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.

  PMID: 26410354 BACKGROUND

• 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.

  PMID: 21210891 BACKGROUND

MeSH Terms

Interventions

Esketamine; Ketamine; Sevoflurane

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Fang Tan

  Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 11, 2022
• Study Start: March 28, 2022
• Primary Completion: May 14, 2023
• Study Completion: May 17, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)