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Comparison of Sedation by Esketamine and Sevoflurane

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ClinicalTrials.gov Identifier: NCT05011214
Recruitment Status : Enrolling by invitation
First Posted : August 18, 2021
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Eye & ENT Hospital of Fudan University

Tracking Information
First Submitted Date  ICMJE August 7, 2021
First Posted Date  ICMJE August 18, 2021
Last Update Posted Date April 5, 2022
Actual Study Start Date  ICMJE September 20, 2021
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2021)
eye position scale [ Time Frame: during the surgery ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2022)
  • 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
  • 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.
  • 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 mins ]
    the time of the length of stay in the post-anesthesia care unit
  • Mean blood pressure 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 extubation;1minutes after extubation,3 minutes after extubation ]
    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 mins ]
    extubation time
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2021)
  • the incidence of body motion [ Time Frame: during the surgery ]
    a clinically observable active movement of body caused by procedural stimulation.(1= have body movement; 0= no body movement)
  • the incidence of apnea [ Time Frame: during the surgery ]
    the incidence ofapnea caused by anesthetic agents
  • Intraocular pressure [ Time Frame: the time after intubation and topical anesthesia within 1 minute ]
    Intraocular pressure after indution
  • 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
  • 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=inconsolabe crying; 5=severe restlessness, disorientation.
  • PAED score [ Time Frame: scores at the time point of 1 minutes after extubation ]
    pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable. Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation.
  • 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 mins ]
    the time of the length of stay in the post-anesthesia care unit
  • Blood pressure [ Time Frame: 1minutes before induction;1minutes after induction;1minutes before extubation;1minutes after extubation,3 minutes after extubation ]
    DBP, diastolic blood pressure; MBP, mean blood pressure; SBP, systolic blood pressure.
  • Heart rate [ Time Frame: 1minutes before induction;1minutes after induction;1minutes before extubation;1minutes after extubation,3 minutes after extubation ]
    Heart rate
  • extubation time [ Time Frame: duration from the time that patients arrived in PACU to the time of extubation, average 10 mins ]
    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 Sedation by Esketamine and Sevoflurane
Official Title  ICMJE Comparison of Sedation by Esketamine and Sevoflurane for Short Ophthalmological Procedure in Children
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Sevoflurane
Intervention  ICMJE
  • 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 Name: Sevoflurane Inhalation Solution
  • 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 Name: s(+)ketamine
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Sevoflurane
  • 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.
    Intervention: Drug: Esketamine
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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 16, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 20, 2022
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05011214
Other Study ID Numbers  ICMJE 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 August 2021

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