Ophthalmic AbnormalitiesNCT06053489
Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients
An observational study of Ophthalmic Abnormalities and Pediatric Disorder, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Ophthalmic Abnormalities, Pediatric Disorder
- What is being tested?
- general anesthesia with remimazolam
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2023to 31 Aug 2024
- Phase
- Observational
- 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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia
Who may be able to join
- Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia
- When anesthesia was induced and maintained with remimazolam, or anesthesia was induced with propofol and maintained with sevoflurane.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients Who Underwent Ophthalmic Surgery Under General Anesthesia
The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) has a short context-sensitive half-life of 7.5 minutes, and the time it takes from the end of anesthesia until the patient wakes up is predictable. According to a study by Yang X et al., administering a small amount of remimazolam (0.2 mg/kg) intravenously at the end of general anesthesia using sevoflurane reduced the incidence of emergence agitation. However, very few studies have evaluated the use of remimazolam in general anesthesia in pediatric patients.
Read the detailed description
- The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. It has the advantage of being able to induce anesthesia without securing an intravenous route and causing less irritation to the airway. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Emergence agitation can cause physical damage to the patient, workload in the recovery room, and dissatisfaction of the caregiver.
- Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) is a benzodiazepine drug used for inducing and maintaining general anesthesia and for sedation during procedures. When remimazolam is used as a general anesthetic, it has the advantage of being metabolized quickly by enzymes in the liver compared to propofol, has a short context-sensitive half-life of 7.5 minutes, and can be reversed with flumazenil. Therefore, during general anesthesia using remimazolam, the time it takes from the end of anesthesia until the patient wakes up is predictable. According to a study by Yang X et al., administering a small amount of remimazolam (0.2 mg/kg) intravenously at the end of general anesthesia using sevoflurane reduced the incidence of emergence agitation.
- However, very few studies have evaluated the use of remimazolam in general anesthesia in pediatric patients and its effect on endotracheal extubation time after anesthesia in operating room, emergence agitation, pain, and discharge time in the postanesthesia care unit (PACU).
- Conditions
- Ophthalmic Abnormalities, Pediatric Disorder
- Being tested
- general anesthesia with remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesia with remimazolamOther
general anesthesia with remimazolam in pediatric patients undergoing ophthalmic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to extubation
Time to extubation after the end of general anesthesia
Measured: Immediate after the end of general anesthesia
Secondary outcomes (4)
Time for post-anesthesia recovery
Time taken until the patient can leave the PACU. The post-anesthesia recovery score (modified Aldrete score) is used for assessment of patient's activity, respiration, blood pressure, consciousness, and peripheral oxygen saturation. A score 9 points or more is required for discharge from the PACU.
Measured: From the time of immediate after entering the PACU until until achieving post-anesthesia recovery score of 9 or more, assessed up to 4 hours
Postoperative pain
Visual analog scale (VAS) is going to be measured after entering the PACU. The VAS is a validated, subjective measure for acute and chronic pain. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Immediate after entering the PACU, 15 minutes after entering the PACU
Incidence of emergence delirium
Emergence delirium measured after entering the PACU
Measured: Immediate after entering the PACU, 15 minutes after entering the PACU
Adverse events and complications
Adverse events and complications that occur during anesthesia and recovery from anesthesia
Measured: during general anesthesia, and recovery after general anesthesia, up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start31 Jul 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmic AbnormalitiesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital, Yangsan, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053489
- Sponsor's protocol ID
- 2023-09-09
- Status last verified
- Oct 2024
- First submitted
- 9 Sep 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients Who Underwent Ophthalmic Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06053489
- Acronym / sponsor ID
- 2023-09-09
- Conditions
- Ophthalmic Abnormalities, Pediatric Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 25 Sep 2023 (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.
The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) has a short context-sensitive half-life of 7.5 minutes, and the time it takes from the end of anesthesia until the patient wakes up is predictable. According to a study by Yang X et al., administering a small amount of remimazolam (0.2 mg/kg) intravenously at the end of general anesthesia using sevoflurane reduced the incidence of emergence agitation. However, very few studies have evaluated the use of remimazolam in general anesthesia in pediatric patients.
Detailed description
- The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. It has the advantage of being able to induce anesthesia without securing an intravenous route and causing less irritation to the airway. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Emergence agitation can cause physical damage to the patient, workload in the recovery room, and dissatisfaction of the caregiver.
- Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) is a benzodiazepine drug used for inducing and maintaining general anesthesia and for sedation during procedures. When remimazolam is used as a general anesthetic, it has the advantage of being metabolized quickly by enzymes in the liver compared to propofol, has a short context-sensitive half-life of 7.5 minutes, and can be reversed with flumazenil. Therefore, during general anesthesia using remimazolam, the time it takes from the end of anesthesia until the patient wakes up is predictable. According to a study by Yang X et al., administering a small amount of remimazolam (0.2 mg/kg) intravenously at the end of general anesthesia using sevoflurane reduced the incidence of emergence agitation.
- However, very few studies have evaluated the use of remimazolam in general anesthesia in pediatric patients and its effect on endotracheal extubation time after anesthesia in operating room, emergence agitation, pain, and discharge time in the postanesthesia care unit (PACU).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia
Key inclusion criteria (2 listed)
- Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia
- When anesthesia was induced and maintained with remimazolam, or anesthesia was induced with propofol and maintained with sevoflurane.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| general anesthesia with remimazolamgeneral anesthesia with remimazolam in pediatric patients undergoing ophthalmic surgery | Other | – |
Primary outcome
Time to extubation
Time frame: Immediate after the end of general anesthesia
Time to extubation after the end of general anesthesia
4 secondary outcomes
Time for post-anesthesia recovery
Time frame: From the time of immediate after entering the PACU until until achieving post-anesthesia recovery score of 9 or more, assessed up to 4 hours
Postoperative pain
Time frame: Immediate after entering the PACU, 15 minutes after entering the PACU
Incidence of emergence delirium
Time frame: Immediate after entering the PACU, 15 minutes after entering the PACU
Adverse events and complications
Time frame: during general anesthesia, and recovery after general anesthesia, up to 1 day
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 1 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Hee Young Kim, MD, PhD principal investigator
Pusan National University Yangsan Hospital, Yangsan, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmic Abnormalities and Pediatric Disorder, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 1 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 1 Nov 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 South Korea. 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?
Time to extubation (time frame: Immediate after the end of general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2024.