Sevoflurane Clinical Trial
Official title:
Comparison of Sedation by Esketamine and Sevoflurane for Short Ophthalmological Procedure in Children
Verified date | August 2021 |
Source | Eye & ENT Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Eye & ENT Hospital of Fudan University |
China,
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
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 |
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