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Can a simple puff before surgery keep kids breathing safely?

NCT ID NCT06624696

Prevention Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether inhaling a drug called penehyclidine hydrochloride before surgery can prevent breathing complications in children aged 3 to 7 who are at higher risk. The trial involves 204 kids undergoing minor eye surgery with sevoflurane anesthesia. Researchers will compare the rate of breathing problems like coughing, airway blockage, or spasms between those who get the drug and those who get a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 204 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 7 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Pediatric patients aged 3 to 7 years. 2. Scheduled to undergo ophthalmic surgery. 3. Judged to be at risk of PRAEs (with at least one parentally reported risk factor for the PRAEs, including history of a recent cold, wheezing during exercise, wheezing more than three times in the past 12 months, nocturnal dry cough, eczema, or a family history of asthma, rhinitis, eczema, or exposure to passive smoke). Exclusion Criteria: 1. American Society of Anesthesiologists (ASA) physical classification ≥ IV. 2. Known cardiopulmonary diseases (eg. uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumors, or structural lung diseases). 3. Severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (Child-Pugh grade C); 4. Neurological disorders. 5. Neuromuscular diseases. 6. Contraindication for PHC. 7. Inhalation of β2-receptor activator, M-receptor blockers and/or glucocorticoids within 1 month before surgery. 8. Allergy to anticholinergic drugs. 9. Use of endotracheal tube (ETT) for ventilation. 10. Known difficult airway. 11. Severe upper respiratory tract infections (URTIs) and the anesthesiologist recommended delaying surgery. 12. Participation in other clinical trial during the last month or within the six half-life periods of the study drug used in the last trial. 13. Parents refusing to allow their children to participate. 14. Obesity, with a body mass index (BMI) over 95th percentile according to the WHO guideline.

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Conditions

The condition(s) this trial relates to.

allergic respiratory disease hypersensitivity reaction disease Respiratory Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anticholinergics High risk Inhalation therapy; complications Perioperative respiratory adverse events Respiratory hypersensitivity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shenzhen Eye Hospital

    RECRUITING

    Shenzhen, Guangdong, 518040, China

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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