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Comparison of Esketamine and Sevoflurane on Emergence Agitation

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ClinicalTrials.gov Identifier: NCT05321160
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Eye & ENT Hospital of Fudan University

Tracking Information
First Submitted Date  ICMJE March 25, 2022
First Posted Date  ICMJE April 11, 2022
Last Update Posted Date April 25, 2022
Actual Study Start Date  ICMJE March 10, 2021
Estimated Primary Completion Date April 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2022)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2022)
  • 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
  • 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.
  • the incidence of respiratory depression [ Time Frame: during the surgery ]
    decreased tidal volume or weak chest undulation
  • the incidence of desaturation [ Time Frame: during the surgery ]
    the incidence of oxygen saturation below 95% caused by anesthetic agents
  • intraocular pressure [ Time Frame: the time after intubation and topical anesthesia within 1 minute ]
    intraocular pressure after induction
  • respiration rate [ Time Frame: 1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation ]
    respiration rate
  • mean blood pressure [ Time Frame: 1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation ]
    mean blood pressure
  • heart rate [ Time Frame: 1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation ]
    heart rate
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2022)
  • 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
  • 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.
  • the incidence of respiratory depression [ Time Frame: during the surgery ]
    decreased tidal volume or weak chest undulation
  • the incidence of desaturation [ Time Frame: during the surgery ]
    the incidence of oxygen saturation below 95% caused by anesthetic agents
  • intraocular pressure [ Time Frame: the time after intubation and topical anesthesia within 1 minute ]
    intraocular pressure after induction
  • requirements for additional propofol [ Time Frame: during the surgery ]
    If the target level of sedation was not achieved, an additional 0.1mg/kg propofol was injected and repeated if necessary
  • mean blood pressure [ Time Frame: 1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation ]
    mean blood pressure
  • heart rate [ Time Frame: 1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation ]
    heart rate
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Esketamine and Sevoflurane on Emergence Agitation
Official Title  ICMJE Comparison of Esketamine and Sevoflurane on Emergence Agitation for Pediatric Ophthalmological Procedure
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Emergence Agitation
Intervention  ICMJE
  • Drug: Esketamine
    0.5 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery
    Other Name: s(+)ketamine
  • Drug: Sevoflurane
    5% sevoflurane for induction and 3-4% sevoflurane for maintain
    Other Name: Sevoflurane Inhalation Solution
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Esketamine
  • 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.
    Intervention: Drug: Sevoflurane
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2022)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 17, 2022
Estimated Primary Completion Date April 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 72 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Fang Tan, Phd 8613611716000 tanfang@eentanesthesia.com
Contact: Wenjing Yi 8613636547402 ywjeline@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05321160
Other Study ID Numbers  ICMJE EA and esketamine
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Eye & ENT Hospital of Fudan University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eye & ENT Hospital of Fudan University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fang Tan Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
PRS Account Eye & ENT Hospital of Fudan University
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP