ChalazionSEVO-PEDNCT07450495
Effect of Different Concentrations of Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Surgery
A study testing Sevoflurane in people with Chalazion, run by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong at 1 site in China.
Trial summary
This randomized controlled trial aims to compare the effectiveness and safety of 6% versus 8% sevoflurane inhalation induction in pediatric patients undergoing minor ophthalmic surgery. The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Chalazion
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2025to 26 Feb 2026
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 to 6 years (12-72 months)
- Scheduled to undergo minor ophthalmic surgery (e.g., chalazion excision) under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I
- Assessed as suitable for inhalation anesthesia by anesthesiologists
- Written informed consent obtained from parents or legal guardians
Who cannot join
- ASA physical status II or higher
- Known hepatic or renal dysfunction
- Congenital heart disease
- History of malignant hyperthermia
- Known allergy to sevoflurane
- History of asthma or severe respiratory disease
Show all 9Show fewer
- Upper respiratory tract infection within the past 4 weeks
- Anticipated difficult airway
- Refusal of participation by parents or legal guardians
Trial locations and contacts
1 site in 1 country.
China1 site
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, 515041
About this study
Official title: Effectiveness and Safety of 6% Versus 8% Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Minor Surgery: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effectiveness and safety of 6% versus 8% sevoflurane inhalation induction in pediatric patients undergoing minor ophthalmic surgery. The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes include hemodynamic parameters, induction time, recovery time, and adverse events.
- Conditions
- Chalazion
- Being tested
- Sevoflurane
- Medical subject headings
- Chalazion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane,Sevorane,Ultane
Sevoflurane inhalation anesthesia was used for induction and maintenance of general anesthesia in pediatric patients undergoing minor ophthalmic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane 8% Group | Active comparator | Participants received 8% sevoflurane inhalation for anesthesia induction via face mask. Receives: Drug: Sevoflurane |
| Sevoflurane 6% Group | Experimental | Participants received 6% sevoflurane inhalation for anesthesia induction via face mask. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAED score
Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale ranges from 0 to 20, with higher scores indicating more severe emergence delirium (worse outcome).
Measured: Within 30 minutes after recovery
Secondary outcomes (7)
Induction time
Time from face mask placement to loss of eyelash reflex, measured in seconds.
Measured: Immediately after anesthesia induction
Recovery time
Time from discontinuation of sevoflurane to full recovery of consciousness, measured in minutes.
Measured: Immediately after anesthesia discontinuation
Minimum alveolar concentration (MAC)
Minimum alveolar concentration (MAC) values recorded during anesthesia maintenance.
Measured: Perioperatively
Respiratory depression
Incidence of respiratory depression recorded during the perioperative period.
Measured: Perioperatively
Hypoxia
Incidence of hypoxia recorded during the perioperative period.
Measured: Perioperatively
Cough
Incidence of cough recorded during the perioperative period.
Measured: Perioperatively
Nausea and vomiting
Incidence of nausea and vomiting recorded during the postoperative recovery period.
Measured: Immediately after anesthesia until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start25 Feb 2025
- Primary completion25 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChalazionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laiwen Lv, Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450495
- Sponsor's protocol ID
- EC20240514(3)-P38
- Acronym
- SEVO-PED
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 25 Aug 2026
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of 6% Versus 8% Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Minor Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07450495
- Acronym / sponsor ID
- SEVO-PED / EC20240514(3)-P38
- Conditions
- Chalazion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong KongUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 4 Mar 2026 (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.
This randomized controlled trial aims to compare the effectiveness and safety of 6% versus 8% sevoflurane inhalation induction in pediatric patients undergoing minor ophthalmic surgery. The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes include hemodynamic parameters, induction time, recovery time, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane 8% Group | Active comparator | Drug: SevofluraneParticipants received 8% sevoflurane inhalation for anesthesia induction via face mask. |
| Sevoflurane 6% Group | Experimental | Drug: SevofluraneParticipants received 6% sevoflurane inhalation for anesthesia induction via face mask. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 1 to 6 years (12-72 months)
- Scheduled to undergo minor ophthalmic surgery (e.g., chalazion excision) under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I
- Assessed as suitable for inhalation anesthesia by anesthesiologists
- Written informed consent obtained from parents or legal guardians
Key exclusion criteria (9 listed)
- ASA physical status II or higher
- Known hepatic or renal dysfunction
- Congenital heart disease
- History of malignant hyperthermia
- Known allergy to sevoflurane
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 |
|---|---|---|
| SevofluraneAlso: Sevorane,Sevorane,UltaneSevoflurane inhalation anesthesia was used for induction and maintenance of general anesthesia in pediatric patients undergoing minor ophthalmic surgery. | Drug | Sevoflurane 6% Group, Sevoflurane 8% Group |
Primary outcome
PAED score
Time frame: Within 30 minutes after recovery
Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale ranges from 0 to 20, with higher scores indicating more severe emergence delirium (worse outcome).
7 secondary outcomes
Induction time
Time frame: Immediately after anesthesia induction
Recovery time
Time frame: Immediately after anesthesia discontinuation
Minimum alveolar concentration (MAC)
Time frame: Perioperatively
Respiratory depression
Time frame: Perioperatively
Hypoxia
Time frame: Perioperatively
Cough
Time frame: Perioperatively
Nausea and vomiting
Time frame: Immediately after anesthesia until discharge
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 25 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane in people with Chalazion, run by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong 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 5 inclusion and 9 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 25 Aug 2026. 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?
PAED score (time frame: Within 30 minutes after recovery). 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 25 Aug 2026.