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A tiny dose of an old drug might stop Post-Surgery brain fog in seniors

NCT ID NCT05401058

Prevention Sponsor: RenJi Hospital 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether a single low dose of droperidol, given just before the end of surgery, can prevent postoperative delirium—a state of confusion and disorientation—in adults aged 65 and older undergoing non-cardiac surgery. About 800 participants will receive either droperidol or a placebo injection, and researchers will track delirium rates, severity, hospital stay, and cognitive function over six months. If it works, this could offer a simple preventive strategy to protect older patients' mental clarity after major operations.

What this could mean

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

Active substance
droperidol (a low-dose antipsychotic medication given by injection before the end of surgery)
What this could lead to
If effective, this could offer a simple, low-cost way to prevent postoperative delirium in older adults, potentially improving recovery and quality of life after surgery.
What could go wrong
The trial is still in progress, and results may not confirm a benefit. Droperidol can have side effects, including heart rhythm changes, and its use in this setting needs careful evaluation.

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

797 people

The number who actually took part.

Started

Nov 2022

Finished

Jul 2025

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: * Age≥65 years * American Society of Anesthesiologists (ASA): I-III * Planning to undergo elective non-cardiac surgery under general anesthesia with endotracheal intubation, including digestive, orthopedic, urologic and gynecological surgery * Estimated operation time more than 2 hours * Not expected to be admitted to ICU postoperatively * Proficient in Chinese * Informed consent Exclusion Criteria: * Morbid obesity with BMI \>35 kg/m2; * History of psychological and neurological diseases, such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc; * Corrected QT (QTc) of electrocardiogram\> 500ms; * Preoperative liver insufficiency (Child Pugh grade C); * End-stage renal disease requiring dialysis; * Severe heart failure \[Metablic equivalent (METs)\<4\]; * Allergic to droperidol; * Inability to communicate due to coma or dementia in preoperative period; * Preoperative delirium, assessed by 3D-CAM; * More than three standard alcoholic drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits); * Participating in conflicting clinical trials; * Expected to have an additional operation within 7 days after the index operation.

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases digestive system disorder Emergence Delirium female reproductive system disorder urinary system disorder

As listed by the trial registrant

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

Digestive system disease Gynecological disease Orthopedic surgery Urologic diseases

Contacts and locations

Locations

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, China

  • ChangHai Hospital

    Shanghai, China

  • Henan Provincial People Hospital

    Zhengzhou, Henan, China

  • Peking University International Hospital

    Beijing, China

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Pudong, Shanghai Municipality, 200127, China

  • Second hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)

    Chengdu, Sichuan, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, China

  • The first Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.