New hope for faster surgery recovery: drug may cut Wake-Up time
NCT ID NCT04713358
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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542 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Dec 2023
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Renji Hospital
Shanghai, Shanghai Municipality, 200127, China
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Shanghai Tong Ren Hospital
Shanghai, Shanghai Municipality, 200000, China
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The First Affiliated Hospital of Guangxi Medical University
Guangxi, Guangxi, 530000, China
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The First Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, 450000, China
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