Comparison of Sedation by Esketamine and Sevoflurane

Comparison of Sedation by Esketamine and Sevoflurane for Short Ophthalmological Procedure in Children

Pediatric diseases，including congenital cataract,，corneal injury，corneal ulcer, usually need suture removal and ophthalmic examination after Surgery for several days. Unfortunately, it remains a great challenge to achieve successful sedation due to children's noncooperation. Sevoflurane is one of the most often used anesthesia agents to provide deep sedation. Although sevoflurane has been used for pediatric anesthesia with successful keep spontaneous breathing without intubation, it should be noted that sevoflurane often results in air pollution under the open airway background and postoperative agitation.

Esketamine is the S (+) isomer of ketamine, which produces a dissociated state with minimal risk of airway compromise or apnea. It has enhanced analgesic potency and faster elimination compared to ketamine. However, it may also cause delirium during the recovery time. Based on these experiences on ketamine, we compared the effectiveness of esketamine and sevoflurane for short ophthalmological procedure in pediatric patients.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sevoflurane
• Intervention / Treatment: Drug: Sevoflurane; Drug: Esketamine

Detailed Description

Pediatric diseases，including congenital cataract,，corneal injury，corneal ulcer, usually need suture removal and ophthalmic examination after Surgery for several days. Unfortunately, it remains a great challenge to achieve successful sedation to avoid body movement and keep perfect eye position due to children's noncooperation. Thus, appropriate sedative agents therefore need to be administrated to perform this minor surgery. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been used for successful keeping spontaneous breathing without tracheal intubation. It should be noted that sevoflurane often results in air pollution under the open airway background and emergence agitation. High concentrations of sevoflurane may causes respiratory depression due to the decrease in tidal volume during spontaneous ventilation.

Ketamine is widely used for procedural sedation, which produces a dissociated state with minimal risk of airway compromise or apnea. Esketamine is the S (+) isomer of ketamine, It has enhanced analgesic potency and faster elimination compared to ketamine. However, it may also cause agitation during the recovery time. Based on these experiences on ketamine, we compared the effectiveness of esketamine and sevoflurane for short ophthalmological procedure in pediatric patients.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient who needed suture removal and ophthalmic examination

Exclusion Criteria:

• previous coronary heart disease,hypertension, arterial aneurysm, epilepsia, intracranial mass of benign or malign nature

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group S; patients were anesthetized by face mask with 5 vol% sevoflurane with total 5 L/min-1 fresh gas flow. Anaesthesia was maintained by continuously using 3-4% sevoflurane.	Drug: Sevoflurane; All patients received 0.01 mg/kg atropine and 1ug/kg dexmedetomidine iv as premedication.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; Other Names: Sevoflurane Inhalation Solution
Experimental: group E; patients received 0.5mg/kg IV esketamine at first, after surgical field disinfection, another 0.25mg/kg IV esketamine was administered. Then 1mg/kg propofol was administered every 5 minutes after intubation.	Drug: Esketamine; All patients received 0.1 mg/kg atropine and 1ug/kg dexmedetomidine iv as premedication.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.; Other Names: s(+)ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eye position scale	1=The inner and outer canthus line across the central cornea; 2= Inferior limbus does not exceed the inner and outer canthus line; 3= Inferior limbus exceed the inner and outer canthus line.	during the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of respiratory depression	decreased tidal volume or weak chest undulation	during the surgery
the incidence of desaturation	the incidence of oxygen saturation below 95% caused by anesthetic agents	during the surgery
Intraocular pressure	Intraocular pressure after induction	the time after intubation and topical anesthesia within 1 minute
requirements for additional propofol	If the target level of sedation was not achieved, an additional 0.1mg/kg propofol was injected and repeated if necessary	during the surgery
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
length of stay in the post-anesthesia care unit	the time of the 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 mins
Mean blood pressure pressure	mean blood pressure	1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation
Heart rate	Heart rate	1minutes before induction;1minutes after induction;1minutes before extubation;1minutes after extubation,3 minutes after extubation
extubation time	extubation time	duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 mins

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Principal Investigator: Fang Tan, Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Publications and helpful links

General Publications

• Green SM, Roback MG, Kennedy RM, Krauss B. Clinical practice guideline for emergency department ketamine dissociative sedation: 2011 update. Ann Emerg Med. 2011 May;57(5):449-61. doi: 10.1016/j.annemergmed.2010.11.030. Epub 2011 Jan 21.
• Cao Q, Lin Y, Xie Z, Shen W, Chen Y, Gan X, Liu Y. Comparison of sedation by intranasal dexmedetomidine and oral chloral hydrate for pediatric ophthalmic examination. Paediatr Anaesth. 2017 Jun;27(6):629-636. doi: 10.1111/pan.13148. Epub 2017 Apr 17.
• Krishnappa S, Kundra P. Optimal anaesthetic depth for LMA insertion. Indian J Anaesth. 2011 Sep;55(5):504-7. doi: 10.4103/0019-5049.89887.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Anticipated): April 20, 2022

Study Registration Dates

• First Submitted: August 7, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: sevoflurane; esketamine; sedation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Platelet Aggregation Inhibitors; Psychotropic Drugs; Antidepressive Agents; Anesthetics, Inhalation; Ketamine; Sevoflurane; Esketamine
• Other Study ID Numbers: esketamine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No