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Two-Drug cocktail may ease agitation in elderly after anesthesia

NCT ID NCT05769530

Symptom relief Sponsor: Lili Jia Source: ClinicalTrials.gov ↗

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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.
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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 Results may not be published yet.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)
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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
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First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether giving two drugs—dexmedetomidine and nalbuphine—during surgery helps elderly patients (age 60+) recover more calmly from general anesthesia. The goal was to reduce agitation, pain, and coughing right after waking up. 360 patients were split into groups, with one group receiving the drug combo and the other a placebo. The main focus was on how agitated patients were in the first 30 minutes after the breathing tube was removed.

What this could mean

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

Active substance
Dexmedetomidine and nalbuphine
What this could lead to
If it works, this could lead to a standard way to help elderly patients wake up more comfortably after surgery, with less confusion and pain.
What could go wrong
This is a small, completed Phase 4 trial. Results may not apply to all elderly patients or surgeries, and the drugs can cause side effects like slow heart rate or breathing problems.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

360 people

The number who actually took part.

Started

May 2023

Finished

Dec 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

60 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) Age ≥60, gender unlimited; (2) ventilator assisted ventilation after endotracheal intubation; (3) General anesthesia surgery; Exclusion Criteria: * (1) Allergy to the drugs used in this study; (2) any sedative, analgesic, antiemetic or antipruritic drugs taken 24 hours before the operation; (3) History of severe bradycardia (heart rate \< 50 beats/min); (4) moderate to severe hepatic and renal dysfunction; (5) Patients with neurological diseases;

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As listed by the trial registrant

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

General anesthetics，emergence agitation

Contacts and locations

Locations

  • Tian Jin First Center Hospital

    Tianjin, China

  • TianJin First Central Hospital

    Tianjin, Tianjin Municipality, 300192, China