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Simple sedative may shield seniors from Post-Surgery confusion

NCT ID NCT06963112

Symptom relief Sponsor: Chinese PLA General Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This study tests whether giving a small amount of the sedative midazolam during anesthesia can lower the risk of delirium (sudden confusion) and anxiety in older adults after surgery. About 612 patients aged 65-85 having non-heart, non-brain surgery will be randomly assigned to receive either midazolam or a placebo. The goal is to see if this common drug can help prevent mental side effects after an operation.

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

612 people

The number who actually took part.

Started

Sep 2025

Finished

Jun 2026

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 to 85 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. 65 ≤ Age ≤ 85 years old; 2. Elective surgery under general anesthesia, with an estimated surgery time of ≥ 2 hours; 3. Non cardiac surgery, non neurosurgical surgery; 4. ASA grades I-III; 5. Agree to participate and sign the informed consent form; Exclusion Criteria: 1. Preoperative history of comorbidities such as depression and schizophrenia; 2. History of neurological disorders, moderate stroke; 3. Long term use of benzodiazepines before surgery; 4. BMI≤18.5/BMI≥30 kg/m2 5. There is cognitive impairment, which is determined based on Mini Mental State Examination (MMSE) scores below the standard threshold; 6. There are communication barriers, such as severe dementia, language barriers, and severe hearing or visual impairments; 7. There are any contraindications for the use of midazolam (contraindications for patients with severe respiratory dysfunction, patients with severe liver and kidney damage, patients with sleep apnea syndrome, and patients known to be allergic to benzodiazepines); 8. Preoperative severe liver and kidney dysfunction; 9. Patients expected to enter the ICU after surgery;

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder delirium

As listed by the trial registrant

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

Anxiety Delirium

Contacts and locations

Locations

  • Changhai Hostpital of Navy Medical University

    Shanghai, China

  • China-Japan Union Hospital of Jilin University

    Jilin City, China

  • Chinese PLA General Hospital

    Beijing, 100853, China

  • The First Affiliate Hospital of Guangxi Medical University

    Guangxi, Guangxi, China

  • The Second Norman Bethune Hospital of Jilin University

    Jilin City, China

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