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NCT Number: NCT05321160

Comparison of the Sedation Effect of Esketamine and Sevoflurane for Pediatric Ophthalmological Procedure

Emergence agitation is the most common reason for post-anesthesia care unit delay. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been successfully used for keeping spontaneous breathing without tracheal intubation. However, sevoflurane may cause emergence agitation as the incidence varied from 10%-80%. Although there are many sedative agents to reduce its incidence, such as propofol, midazolam, a2 adrenergic receptor agonists and ketamine, the efficacy remains limited.

Ketamine, a neuroleptic anesthetic agent, contains two optical isomers, s(+)-ketamine (esketamine) and R(-)-ketamine. Esketamine is a right-handed split of ketamine, which has enhanced analgesic potency and lower incidence of psychotropic side effects compared to ketamine. It stimulate breathing due to N-Methyl-D-Aspartate receptor blockade, and could even effectively countered remifentanil-induced respiratory depression. The investigators compared the effectiveness of esketamine and sevoflurane in reducing the incidence of emergence agitation after painless ophthalmological procedure in pediatric patients.

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Key information

Conditions

Adverse Event

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

About this study

Ophthalmological procedure such as suture remove, intraocular pressure (IOP) measurement, slit-lamp and fundoscopy are most frequently performed in operation with minor surgical stimulus, and the the duration of surgery is very short. Several anesthestic agents are available,but it is hard to balance short effect and fast rotation in post-anesthesia care unit. Emergence agitation is the most common reason for post-anesthesia care unit delay. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been successfully used for keeping spontaneous breathing without tracheal intubation. However, sevoflurane may cause emergence agitation as the incidence varied from 10%-80%. Although there are many sedative agents to reduce its incidence, such as propofol, midazolam, a2 adrenergic receptor agonists and ketamine, the efficacy remains limited.

Ketamine, a neuroleptic anesthetic agent, contains two optical isomers, s(+)-ketamine (esketamine) and R(-)-ketamine. Esketamine is a right-handed split of ketamine, which has enhanced analgesic potency and lower incidence of psychotropic side effects compared to ketamine. It stimulate breathing due to N-Methyl-D-Aspartate receptor blockade, and could even effectively countered remifentanil-induced respiratory depression. Additionally, several studies have reported ketamine could reduced agitation, but there is no study about esketamine on emergence agitation. The investigators compared the effectiveness of esketamine and sevoflurane in reducing the incidence of emergence agitation after painless ophthalmological procedure in pediatric patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists physical status 1-2
  • required to remove the stitches by microscope after corneal surgeries

Exclusion criteria

  • psychiatric disorders
  • cardiovascular disorders
  • glaucoma
  • contraindications to nasal intubation

Treatment and study plan

Esketamine

Drug

0.25 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery

Other names: s(+)ketamine

Sevoflurane

Drug

4% sevoflurane for induction and 2-4% sevoflurane for maintain

Other names: Sevoflurane Inhalation Solution

Primary outcomes

  1. the incidence of respiratory depression

    Time frame: duration from the time patient received induction to the time of leaving to the ward, average 1 hour

    respiratory rate <12 times per min or weak chest undulation

  2. the incidence of desaturation

    Time frame: duration from the time patient received induction to the time of leaving to the ward, average 1 hour

    the incidence of oxygen saturation below 95% caused by anesthetic agent.

  3. the incidence of hypotension

    Time frame: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.

    the incidence of systolic blood pressure< 30% of basal systolic blood pressure and lasted >5 minutes.

  4. the incidence of hypertension

    Time frame: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.

    the incidence of systolic blood pressure > 30% of basal systolic blood pressure

  5. the incidence of tachycardia

    Time frame: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.

    the incidence of heart rate increase over 30% of pre-induction and>120 beats per minute.

  6. the incidence of bradycardia

    Time frame: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.

    the incidence of heart rate less than 60 beats per minute

  7. the incidence of emergence agitation

    Time frame: duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes

    the incidence of emergence agitation

Secondary outcomes

  1. length of stay in the post-anesthesia care unit

    Time frame: duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes

    the time of patients staying in post-anesthesia care unit

  2. CPS score

    Time frame: 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.

  3. intraocular pressure

    Time frame: the time after intubation and topical anesthesia within 1 minute

    intraocular pressure after induction

  4. diastolic pressure

    Time frame: 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation

    diastolic pressure

  5. systolic pressure

    Time frame: 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation

    systolic pressure

  6. heart rate

    Time frame: 1minutes before induction; 1minutes before intubation;1minutes after intubation,3 minutes after intubation

    heart rate

  7. extubation time

    Time frame: duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minutes

    extubation time

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

Comparison of Esketamine Versus Sevoflurane Add to Dexmedetomidine-based Sedation for Minor Ophthalmology Procedure in Children: A Randomized Controlled Trial.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2022
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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