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Can a new Opioid-Like drug prevent dangerous blood pressure spikes during anesthesia?

NCT ID NCT07749131

Disease control Sponsor: Shiyou Wei 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This trial tests an experimental drug called tegileridine to find the dose that best prevents sudden rises in blood pressure and heart rate when a breathing tube is placed during general anesthesia. The study includes adults aged 18 to 90 having elective surgery, with separate groups for younger and older patients. Researchers will adjust doses using a special sequential method to pinpoint the effective dose for 90% of people, aiming to make anesthesia safer, particularly for older adults.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tegileridine fumarate (SHR8554), an experimental opioid-like drug given intravenously before anesthesia induction to blunt the body's stress response to breathing tube placement.
What this could lead to
If successful, this could establish a precise dosing guide for tegileridine to make anesthesia induction safer, especially for older adults at higher cardiovascular risk.
What could go wrong
This is an early-phase dose-finding study, so the optimal dose may not be confirmed, and the drug could still cause side effects like sedation or breathing issues.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 108 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 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

18 to 90 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: * American Society of Anesthesiologists (ASA) physical status I-III * Aged ≥18 ears old * Scheduled for elective surgery requiring general anesthesia with tracheal intubation Exclusion Criteria: * Resting Systolic Blood Pressure ≥ 160 mmHg, Diastolic Blood Pressure ≥ 110 mmHg, or heart rate ≥ 110 beats/min on admission to operation room * Continuous opioid medication use for more than 2 weeks within 6 months before the procedure * Known hypersensitivity or allergic reaction to tegileridine, propofol or any excipients of the two drugs * Diagnosed psychiatric disorders or inability to communicate and cooperate with study assessment * Anticipated difficult airway

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As listed by the trial registrant

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

Anesthesia, general Hemodynamics Tracheal intubation

How to take part

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

  1. The places running it

    1 site. 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

  • Shaoyang University Affiliated First Hospital

    Shaoyang, Hunan, 422000, China

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