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New hope for faster surgery recovery: drug may cut Wake-Up time

NCT ID NCT04713358

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 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 Results may not be published yet.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

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This status has not been confirmed recently, so it may be out of date.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 tested whether nalmefene, a drug that blocks opioids, can help patients wake up more quickly and safely after general anesthesia. About 542 adults having elective surgery took part. The goal was to see if nalmefene reduces time spent in the recovery room and improves overall recovery quality.

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

542 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2023

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 65 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. Age is greater than or equal to 18 years old and less than 65 years old 2. Patients who need tracheal intubation under general anesthesia at the right time for orthopedics, urology, and thoracic elective surgery 3. Patients with American Society of Anesthesia physical status I or II 4. BMI≥18kg/m2, and ≤30kg/m2 5. The estimated anesthesia time is 1-4 hours. 6. The intraoperative narcotic analgesics (Sufentanil and Remifentanil) 7. The patient uses electronic intravenous analgesia pump after surgery 8. The patient has informed consent Exclusion Criteria: 1. patients who refused to participate in the study 2. pantients who refuse intravenous analgesia 3. medical history or family history of cognitive disorders,delirium, epilepsy, abalienation, anxiety or depression; 4. recent use of anticholinergic drugs, antidepressants, antianxietics or anticonvulsants 5. medical history of organic brain diseases or cranial vascular diseases 6. patients with a history of allergy to any drug used in the study 7. History of drug addiction and alcoholic intemperance or drug abuse 8. The patient is diagnosed with severe heart and lung disease, or active heart disease, or severe hepatic dysfunction (ChildePugh class C), or severe renal dysfunction (undergoing dialysis before surgery) ,critical illness (preoperative ASA physical status classification \> =3) 9. Participate in other clinical trials within 4 weeks 10. Patients who, during surgery, presented complications (cerebrovascular accidents、heart failure、pneumothorax)or transfer to the intensive care unit during hospitalization, and patients who chose to abandon. 11. Inability to communicate in the preoperative period because of coma, profound dementia, language barrier, or incapacity from severe disease 12. Anesthesia time is \<1 hour or \>4 hours 13. Patients had chronic pain (unsatisfied pain control for at least 1 month).

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Renji Hospital

    Shanghai, Shanghai Municipality, 200127, China

  • Shanghai Tong Ren Hospital

    Shanghai, Shanghai Municipality, 200000, China

  • The First Affiliated Hospital of Guangxi Medical University

    Guangxi, Guangxi, 530000, China

  • The First Affiliated Hospital of Zhengzhou University

    Henan, Zhengzhou, 450000, China

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