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New anesthesia drug aims to make Kids' surgery safer and less painful

NCT ID NCT07510945

Symptom relief Sponsor: Haisco Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new anesthesia drug called cipepofol in 400 children aged 3 to 17 who need surgery. The goal is to see if it works as well as the standard drug propofol for putting kids to sleep before surgery, and if it causes less pain at the injection site. The drug is given through an IV, and researchers will measure how successful and safe the anesthesia is.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

3 to 17 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. Subjects undergoing elective surgery requiring endotracheal intubation. 2. Males or females, aged ≥3 and \<18 years old, with ASA-PS I to IV. 3. For all females of childbearing potential, negative pregnancy test at screening and baseline. Additionally, females of childbearing potential must agree to use birth control (such as condom, intrauterine device \[IUD\], abstinence) from the time of consent until 30 days post study drug administration. 4\. Subjects must be able to adhere to the study visit schedule and complete all study assessments. Exclusion Criteria: * 1\. Subjects whose surgery is emergent, or who need emergency treatment during the surgery, or who need transfusion based on the investigator's judgment. 2\. Contraindications to deep sedation/GA or a history of adverse reaction to sedation/GA. 3\. Subjects known to be allergic to excipients in propofol injection, excipients in cipepofol injectable emulsion (soybean oil, glycerol, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), benzodiazepines, opioids, rocuronium, atropine, and their active ingredients; and to have contraindications to propofol. 4\. Subjects with history or evidence of any of sever system diseases increasing the risk of sedation/anesthesia prior to screening/baseline and deemed unsuitable for participation by the investigator: 5. Subjects with respiratory tract management risks prior to/at screening. 6. Subjects who have participated in clinical studies of any drug within 1 month prior to screening. 7\. Females of childbearing potential (i.e., post-menarche) who are unwilling to use contraception during the entire study period. 8\. Subjects unsuitable for this study for any reason as judged by the investigator.

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As listed by the trial registrant

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

General anesthetic

How to take part

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  1. The official record

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