Adverse EventNCT05321160
Comparison of the Sedation Effect of Esketamine and Sevoflurane for Pediatric Ophthalmological Procedure
A study testing Esketamine and Sevoflurane in people with Adverse Event, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Event
- What is being tested?
- Esketamine and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2022to 17 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- American Society of Anesthesiologists physical status 1-2
- required to remove the stitches by microscope after corneal surgeries
Who cannot join
- psychiatric disorders
- cardiovascular disorders
- glaucoma
- contraindications to nasal intubation
Trial locations and contacts
1 site in 1 country.
China1 site
Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Comparison of Esketamine Versus Sevoflurane Add to Dexmedetomidine-based Sedation for Minor Ophthalmology Procedure in Children: A Randomized Controlled Trial.
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.
Read the detailed description
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.
- Conditions
- Adverse Event
- Being tested
- Esketamine, Sevoflurane
- Keywords
- adverse event, sevoflurane, esketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called s(+)ketamine
0.25 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery
SevofluraneDrug
Also called Sevoflurane Inhalation Solution
4% sevoflurane for induction and 2-4% sevoflurane for maintain
| Study group | Role | What they receive |
|---|---|---|
| Group E | Experimental | 1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 0.25mg·kg-1 esketamine was administered by vein in one minute, and 0.25mg·kg-1 esketamine was given at the beginning of the surgery. Receives: Drug: Esketamine |
| Group S | Active comparator | 1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 4% sevoflurane(FIO2=100%, 3L·min-1) was used to induce anesthesia by mask inhalation and 2-4 % sevoflurane (adjusted according to the depth of the anaesthesia,FIO2=100%, 2L·min-1) was maintained. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of respiratory depression
respiratory rate <12 times per min or weak chest undulation
Measured: duration from the time patient received induction to the time of leaving to the ward, average 1 hour
the incidence of desaturation
the incidence of oxygen saturation below 95% caused by anesthetic agent.
Measured: duration from the time patient received induction to the time of leaving to the ward, average 1 hour
the incidence of hypotension
the incidence of systolic blood pressure< 30% of basal systolic blood pressure and lasted >5 minutes.
Measured: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of hypertension
the incidence of systolic blood pressure > 30% of basal systolic blood pressure
Measured: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of tachycardia
the incidence of heart rate increase over 30% of pre-induction and>120 beats per minute.
Measured: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of bradycardia
the incidence of heart rate less than 60 beats per minute
Measured: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of emergence agitation
the incidence of emergence agitation
Measured: duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes
Secondary outcomes (7)
length of stay in the post-anesthesia care unit
the time of patients staying in post-anesthesia care unit
Measured: duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes
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.
Measured: scores at the time point of 1 minutes after extubation
intraocular pressure
intraocular pressure after induction
Measured: the time after intubation and topical anesthesia within 1 minute
diastolic pressure
diastolic pressure
Measured: 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation
systolic pressure
systolic pressure
Measured: 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation
heart rate
heart rate
Measured: 1minutes before induction; 1minutes before intubation;1minutes after intubation,3 minutes after intubation
extubation time
extubation time
Measured: duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start28 Mar 2022
- Primary completion14 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Adverse EventStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang Tan, Principal investigator, Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321160
- Sponsor's protocol ID
- EA and esketamine
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liao R, Li JY, Liu GY. Comparison of sevoflurane volatile induction/maintenance anaesthesia and propofol-remifentanil total intravenous anaesthesia for rigid bronchoscopy under spontaneous breathing for tracheal/bronchial foreign body removal in children. Eur J Anaesthesiol. 2010 Nov;27(11):930-4. doi: 10.1097/EJA.0b013e32833d69ad.
PubMed 20683333Cravero J, Surgenor S, Whalen K. Emergence agitation in paediatric patients after sevoflurane anaesthesia and no surgery: a comparison with halothane. Paediatr Anaesth. 2000;10(4):419-24. doi: 10.1046/j.1460-9592.2000.00560.x.
PubMed 10886700Welborn LG, Hannallah RS, Norden JM, Ruttimann UE, Callan CM. Comparison of emergence and recovery characteristics of sevoflurane, desflurane, and halothane in pediatric ambulatory patients. Anesth Analg. 1996 Nov;83(5):917-20. doi: 10.1097/00000539-199611000-00005.
PubMed 8895263White PF, Schuttler J, Shafer A, Stanski DR, Horai Y, Trevor AJ. Comparative pharmacology of the ketamine isomers. Studies in volunteers. Br J Anaesth. 1985 Feb;57(2):197-203. doi: 10.1093/bja/57.2.197.
PubMed 3970799Patrizi A, Picard N, Simon AJ, Gunner G, Centofante E, Andrews NA, Fagiolini M. Chronic Administration of the N-Methyl-D-Aspartate Receptor Antagonist Ketamine Improves Rett Syndrome Phenotype. Biol Psychiatry. 2016 May 1;79(9):755-764. doi: 10.1016/j.biopsych.2015.08.018. Epub 2015 Aug 24.
PubMed 26410354Eich C, Verhagen-Henning S, Roessler M, Cremer F, Cremer S, Strack M, Russo SG. Low-dose S-ketamine added to propofol anesthesia for magnetic resonance imaging in children is safe and ensures faster recovery--a prospective evaluation. Paediatr Anaesth. 2011 Feb;21(2):176-8. doi: 10.1111/j.1460-9592.2010.03489.x. No abstract available.
PubMed 21210891
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Esketamine Versus Sevoflurane Add to Dexmedetomidine-based Sedation for Minor Ophthalmology Procedure in Children: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05321160
- Acronym / sponsor ID
- EA and esketamine
- Conditions
- Adverse Event
- Keywords
- adverse event, sevoflurane, esketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 14 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E | Experimental | Drug: Esketamine1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 0.25mg·kg-1 esketamine was administered by vein in one minute, and 0.25mg·kg-1 esketamine was given at the beginning of the surgery. |
| Group S | Active comparator | Drug: Sevoflurane1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 4% sevoflurane(FIO2=100%, 3L·min-1) was used to induce anesthesia by mask inhalation and 2-4 % sevoflurane (adjusted according to the depth of the anaesthesia,FIO2=100%, 2L·min-1) was maintained. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status 1-2
- required to remove the stitches by microscope after corneal surgeries
Key exclusion criteria (4 listed)
- psychiatric disorders
- cardiovascular disorders
- glaucoma
- contraindications to nasal intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineAlso: s(+)ketamine0.25 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery | Drug | Group E |
| SevofluraneAlso: Sevoflurane Inhalation Solution4% sevoflurane for induction and 2-4% sevoflurane for maintain | Drug | Group S |
Primary outcome
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
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.
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.
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
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.
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
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
7 secondary outcomes
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
CPS score
Time frame: scores at the time point of 1 minutes after extubation
intraocular pressure
Time frame: the time after intubation and topical anesthesia within 1 minute
diastolic pressure
Time frame: 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation
systolic pressure
Time frame: 1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation
heart rate
Time frame: 1minutes before induction; 1minutes before intubation;1minutes after intubation,3 minutes after intubation
extubation time
Time frame: duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 20683333Liao R, Li JY, Liu GY. Comparison of sevoflurane volatile induction/maintenance anaesthesia and propofol-remifentanil total intravenous anaesthesia for rigid bronchoscopy under spontaneous breathing for tracheal/bronchial foreign body removal in children. Eur J Anaesthesiol. 2010 Nov;27(11):930-4. doi: 10.1097/EJA.0b013e32833d69ad.
- Background: PubMed 10886700Cravero J, Surgenor S, Whalen K. Emergence agitation in paediatric patients after sevoflurane anaesthesia and no surgery: a comparison with halothane. Paediatr Anaesth. 2000;10(4):419-24. doi: 10.1046/j.1460-9592.2000.00560.x.
- Background: PubMed 8895263Welborn LG, Hannallah RS, Norden JM, Ruttimann UE, Callan CM. Comparison of emergence and recovery characteristics of sevoflurane, desflurane, and halothane in pediatric ambulatory patients. Anesth Analg. 1996 Nov;83(5):917-20. doi: 10.1097/00000539-199611000-00005.
- Background: PubMed 3970799White PF, Schuttler J, Shafer A, Stanski DR, Horai Y, Trevor AJ. Comparative pharmacology of the ketamine isomers. Studies in volunteers. Br J Anaesth. 1985 Feb;57(2):197-203. doi: 10.1093/bja/57.2.197.
- Background: PubMed 26410354Patrizi A, Picard N, Simon AJ, Gunner G, Centofante E, Andrews NA, Fagiolini M. Chronic Administration of the N-Methyl-D-Aspartate Receptor Antagonist Ketamine Improves Rett Syndrome Phenotype. Biol Psychiatry. 2016 May 1;79(9):755-764. doi: 10.1016/j.biopsych.2015.08.018. Epub 2015 Aug 24.
- Background: PubMed 21210891Eich C, Verhagen-Henning S, Roessler M, Cremer F, Cremer S, Strack M, Russo SG. Low-dose S-ketamine added to propofol anesthesia for magnetic resonance imaging in children is safe and ensures faster recovery--a prospective evaluation. Paediatr Anaesth. 2011 Feb;21(2):176-8. doi: 10.1111/j.1460-9592.2010.03489.x. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Adverse Event
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Predictive Markers of Immune-related Adverse Events in Patients Treated With Immune Stimulatory Drugs
Cancer
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Tan principal investigator
Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine and Sevoflurane in people with Adverse Event, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05321160, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.