Comparison of Esketamine and Sevoflurane on Emergence Agitation

Sponsor
Eye & ENT Hospital of Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05321160
Collaborator
(none)
80
1
2
14.2
5.6

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
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

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Esketamine and Sevoflurane on Emergence Agitation for Pediatric Ophthalmological Procedure
Actual Study Start Date :
Mar 10, 2021
Anticipated Primary Completion Date :
Apr 14, 2022
Anticipated Study Completion Date :
May 17, 2022

Arms and Interventions

Arm Intervention/Treatment
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:
  • s(+)ketamine
  • 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:
  • Sevoflurane Inhalation Solution
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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.

    3. the incidence of respiratory depression [during the surgery]

      decreased tidal volume or weak chest undulation

    4. the incidence of desaturation [during the surgery]

      the incidence of oxygen saturation below 95% caused by anesthetic agents

    5. intraocular pressure [the time after intubation and topical anesthesia within 1 minute]

      intraocular pressure after induction

    6. respiration rate [1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation]

      respiration rate

    7. mean blood pressure [1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation]

      mean blood pressure

    8. heart rate [1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation]

      heart rate

    9. 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

    Ages Eligible for Study:
    3 Months to 72 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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

    Responsible Party:
    Eye & ENT Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT05321160
    Other Study ID Numbers:
    • EA and esketamine
    First Posted:
    Apr 11, 2022
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eye & ENT Hospital of Fudan University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 25, 2022