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No opioids, less confusion? new study for seniors having gut surgery

NCT ID NCT07603596

Symptom relief Sponsor: Qianfoshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether using a drug combination without opioids during anesthesia can lower the chance of confusion (delirium) after surgery in people 65 and older having gastrointestinal surgery. About 174 participants will be randomly assigned to receive either opioid-free or standard opioid anesthesia. The main goal is to see how many develop delirium within a week after surgery.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 174 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

Jun 2028

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

65 years and older

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. Patients who plan to undergo elective gastrointestinal surgery under general anaesthesia 2. Age ≥65 years 3. American Society of Anaesthesiologists (ASA) grade I-III 4. Body mass index (BMI) of 18.0-30.0 kg/m² 5. Frailty: mFI ≥ 0.27 6. Signed informed consent Exclusion Criteria: 1. Patients undergoing emergency surgery 2. Patients with language disorders or severe hearing or vision impairment that prevent communication 3. Patients with a history of neurological and psychiatric disorders, including Alzheimer's disease (AD), other types of dementia, stroke, and psychosis 4. Patients with long-term use of psychotropic medications (such as clozapine, risperidone, olanzapine, haloperidol, and chlorpromazine) 5. Patients who have undergone cardiac surgery or craniocerebral surgery within the past year 6. Patients who have participated in other relevant clinical trials within the past 3 months 7. Patients with preoperative cognitive impairment (Telephone Interview for Cognitive Status-modified (TICS-m) score ≤ 27), as determined via the TICS-M test 8. Each patient can be included only once, regardless of whether the reason for the second surgery is related to the primary cause 9. Let me know if you need this in a different bullet style (e.g., asterisks) or with indentation adjustments.

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Conditions

The condition(s) this trial relates to.

digestive system cancer digestive system neoplasm Digestive System Neoplasms Emergence Delirium

As listed by the trial registrant

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

Gastrointestinal tumors Postoperative delirium

How to take part

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  1. 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 ↗

  2. 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.

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