Comparison of Sedation by Esketamine and Sevoflurane
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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 Names:
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| 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. |
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 Names:
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Outcome Measures
Primary Outcome Measures
- eye position scale [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.
Secondary Outcome Measures
- the incidence of respiratory depression [during the surgery]
decreased tidal volume or weak chest undulation
- the incidence of desaturation [during the surgery]
the incidence of oxygen saturation below 95% caused by anesthetic agents
- Intraocular pressure [the time after intubation and topical anesthesia within 1 minute]
Intraocular pressure after induction
- requirements for additional propofol [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 [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 [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 [1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation]
mean blood pressure
- Heart rate [1minutes before induction;1minutes after induction;1minutes before extubation;1minutes after extubation,3 minutes after extubation]
Heart rate
- extubation time [duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 mins]
extubation time
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University | Shanghai | Shanghai | China | 200031 |
Sponsors and Collaborators
- Eye & ENT Hospital of Fudan University
Investigators
- Principal Investigator: Fang Tan, Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- esketamine