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Comparison of Sedation by Esketamine and Sevoflurane

Comparison of Sedation by Esketamine and Sevoflurane for Short Ophthalmological Procedure in Children

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05011214
Enrollment
60
Registered
2021-08-18
Start date
2021-09-20
Completion date
2022-04-20
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sevoflurane

Keywords

esketamine, sevoflurane, sedation

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.

Interventions

DRUGSevoflurane

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

DRUGEsketamine

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.

Sponsors

Eye & ENT Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Months to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
eye position scaleduring the surgery1=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

MeasureTime frameDescription
the incidence of desaturationduring the surgerythe incidence of oxygen saturation below 95% caused by anesthetic agents
Intraocular pressurethe time after intubation and topical anesthesia within 1 minuteIntraocular pressure after induction
requirements for additional propofolduring the surgeryIf the target level of sedation was not achieved, an additional 0.1mg/kg propofol was injected and repeated if necessary
CPS scorescores at the time point of 1 minutes after extubationThe 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 depressionduring the surgerydecreased tidal volume or weak chest undulation
Mean blood pressure pressure1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubationmean blood pressure
Heart rate1minutes before induction;1minutes after induction;1minutes before extubation;1minutes after extubation,3 minutes after extubationHeart rate
extubation timeduration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minsextubation time
length of stay in the post-anesthesia care unitduration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minsthe time of the length of stay in the post-anesthesia care unit

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026