Comparison of Sedation by Esketamine and Sevoflurane

Sevoflurane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05011214
• Other study ID #: esketamine
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: September 20, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: August 2021
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: April 20, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Sevoflurane

Intervention

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
• 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.

Locations

Country	Name	City	State
China	Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (3)

Cao Q, Lin Y, Xie Z, Shen W, Chen Y, Gan X, Liu Y. Comparison of sedation by intranasal dexmedetomidine and oral chloral hydrate for pediatric ophthalmic examination. Paediatr Anaesth. 2017 Jun;27(6):629-636. doi: 10.1111/pan.13148. Epub 2017 Apr 17. — View Citation

Green SM, Roback MG, Kennedy RM, Krauss B. Clinical practice guideline for emergency department ketamine dissociative sedation: 2011 update. Ann Emerg Med. 2011 May;57(5):449-61. doi: 10.1016/j.annemergmed.2010.11.030. Epub 2011 Jan 21. — View Citation

Krishnappa S, Kundra P. Optimal anaesthetic depth for LMA insertion. Indian J Anaesth. 2011 Sep;55(5):504-7. doi: 10.4103/0019-5049.89887. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eye position scale	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.	during the surgery
Secondary	the incidence of respiratory depression	decreased tidal volume or weak chest undulation	during the surgery
Secondary	the incidence of desaturation	the incidence of oxygen saturation below 95% caused by anesthetic agents	during the surgery
Secondary	Intraocular pressure	Intraocular pressure after induction	the time after intubation and topical anesthesia within 1 minute
Secondary	requirements for additional propofol	If the target level of sedation was not achieved, an additional 0.1mg/kg propofol was injected and repeated if necessary	during the surgery
Secondary	CPS score	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.	scores at the time point of 1 minutes after extubation
Secondary	length of stay in the post-anesthesia care unit	the time of the 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
Secondary	Mean blood pressure pressure	mean blood pressure	1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation
Secondary	Heart rate	Heart rate	1minutes before induction;1minutes after induction;1minutes before extubation;1minutes after extubation,3 minutes after extubation
Secondary	extubation time	extubation time	duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 mins