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

March 23, 2024 updated by: Eye & ENT Hospital of Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 6 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group E
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
0.25 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery
Other Names:
  • s(+)ketamine
Active Comparator: Group S
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
4% sevoflurane for induction and 2-4% sevoflurane for maintain
Other Names:
  • Sevoflurane Inhalation Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of emergence agitation
Time Frame: 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
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 respiratory depression
Time Frame: 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
duration from the time patient received induction to the time of leaving to the ward, average 1 hour
the incidence of desaturation
Time Frame: 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.
duration from the time patient received induction to the time of leaving to the ward, average 1 hour
the incidence of hypotension
Time Frame: 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.
duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of hypertension
Time Frame: 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
duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of tachycardia
Time Frame: 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.
duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of bradycardia
Time Frame: 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
duration from the time patient received induction to the end of the anesthesia, average 15 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of stay in the post-anesthesia care unit
Time Frame: 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
duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes
CPS score
Time Frame: 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.
scores at the time point of 1 minutes after extubation
intraocular pressure
Time Frame: the time after intubation and topical anesthesia within 1 minute
intraocular pressure after induction
the time after intubation and topical anesthesia within 1 minute
extubation time
Time Frame: duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minutes
extubation time
duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minutes
diastolic pressure
Time Frame: 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation
diastolic pressure
1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation
systolic pressure
Time Frame: 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
heart rate
Time Frame: 1minutes before induction; 1minutes before intubation;1minutes after intubation,3 minutes after intubation
heart rate
1minutes before induction; 1minutes before intubation;1minutes after intubation,3 minutes after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

May 14, 2023

Study Completion (Actual)

May 17, 2023

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

April 2, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA and 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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