Comparison of Sedation by Esketamine and Sevoflurane

Ketamine

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.

Intervention / Treatment

  • Sevoflurane (DRUG)
    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
  • Esketamine (DRUG)
    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.

Condition or Disease

  • Sevoflurane

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 3 Months to 6 Years
    Enrollment: 60 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 20, 2021 ACTUAL
    Primary Completion: Dec 31, 2021 ACTUAL
    Completion Date: Apr 20, 2022 ESTIMATED
    Study First Posted: Aug 18, 2021 ACTUAL
    Last Updated: Mar 25, 2022

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Maximum Age: 6
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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.

    Secondary Outcomes

    • decreased tidal volume or weak chest undulation

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

    • Intraocular pressure after induction

    • If the target level of sedation was not achieved, an additional 0.1mg/kg propofol was injected and repeated if necessary

    • 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 time of the length of stay in the post-anesthesia care unit

    • mean blood pressure

    • Heart rate

    • extubation time

    More Details

    NCT Number: NCT05011214
    Other IDs: esketamine
    Study URL: https://clinicaltrials.gov/study/NCT05011214
    Last updated: Sep 29, 2023