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Comparison of Sedation by Esketamine and Sevflurane

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ClinicalTrials.gov Identifier: NCT05011214
Recruitment Status : Not yet recruiting
First Posted : August 18, 2021
Last Update Posted : August 18, 2021
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 August 18, 2021
Estimated Study Start Date  ICMJE September 20, 2021
Estimated 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 No Changes Posted
Current 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
Original Secondary Outcome Measures  ICMJE Same as current
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 Sevflurane
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 sedationdue 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 anestheisas with successful keep spontaneous breathing without intubation, it should be noted that sevoflurane often results in air pollution under the open airway background and postopertive 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 advoid 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: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Sevoflurane
Intervention  ICMJE
  • Drug: Sevoflurane
    All patients received 0.1 mg/kg atropine and 1ug/kg dexmedetomidine iv as premedication.
  • Drug: Esketamine
    All patients received 0.1 mg/kg atropine and 1ug/kg dexmedetomidine iv as premedication.
    Other Name: s(+)ketamine
Study Arms  ICMJE
  • Active Comparator: group S
    patients were anesthetized by face mask with 8 vol% sevoflurane with total 5 L/min-1 fresh gas flow . Anaesthesia was maintained by continuously using 3.5-4% sevoflurane. The end tidal anaesthetic concentration was mantained betweent 1.3 and 1.4 MAC.
    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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 20, 2022
Estimated 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: Fang Tan, Phd 8613611716000 tanfang@eentanesthesia.com
Contact: Wenjing Yi, MD 8613636547402 ywjeline@hotmail.com
Listed Location Countries  ICMJE Not Provided
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
Responsible Party Eye & ENT Hospital of Fudan University
Study Sponsor  ICMJE Eye & ENT Hospital of Fudan University
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