ResuscitationPhase 4NCT04713358
Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia
A Phase 4 study testing Nalmefene and normal Saline in people with Resuscitation, run by RenJi Hospital at 4 sites in China.
Trial summary
Postoperative recovery is an important part of the patient's experience. A good recovery period is an important guarantee for the recovery of postoperative organs and functions after surgery. However, the delay in awakening after general anesthesia remains one of the biggest challenges facing anesthesiologists. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Resuscitation
- What is being tested?
- Nalmefene and normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 542 participants
- Where
- 4 sitesChina
- Study dates
- 24 Sep 2021to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is greater than or equal to 18 years old and less than 65 years old
- Patients who need tracheal intubation under general anesthesia at the right time for orthopedics, urology, and thoracic elective surgery
- Patients with American Society of Anesthesia physical status I or II
- BMI≥18kg/m2, and ≤30kg/m2
- The estimated anesthesia time is 1-4 hours.
- The intraoperative narcotic analgesics (Sufentanil and Remifentanil)
- The patient uses electronic intravenous analgesia pump after surgery
- The patient has informed consent
Who cannot join
- patients who refused to participate in the study
- pantients who refuse intravenous analgesia
- medical history or family history of cognitive disorders,delirium, epilepsy, abalienation, anxiety or depression;
- recent use of anticholinergic drugs, antidepressants, antianxietics or anticonvulsants
- medical history of organic brain diseases or cranial vascular diseases
- patients with a history of allergy to any drug used in the study
Show all 13Show fewer
- History of drug addiction and alcoholic intemperance or drug abuse
- 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)
- Participate in other clinical trials within 4 weeks
- 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.
- Inability to communicate in the preoperative period because of coma, profound dementia, language barrier, or incapacity from severe disease
- Anesthesia time is <1 hour or >4 hours
- Patients had chronic pain (unsatisfied pain control for at least 1 month).
Trial locations and contacts
4 sites in 1 country.
China4 sites
The First Affiliated Hospital of Guangxi Medical University
Guangxi, Guangxi, 530000
The First Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, 450000
Shanghai Tong Ren Hospital
Shanghai, Shanghai Municipality, 200000
Renji Hospital
Shanghai, Shanghai Municipality, 200127
About this study
Postoperative recovery is an important part of the patient's experience. A good recovery period is an important guarantee for the recovery of postoperative organs and functions after surgery. However, the delay in awakening after general anesthesia remains one of the biggest challenges facing anesthesiologists. The time of resuscitation depends on patient factors, effects of anesthetic factors, duration of surgery, and painful stimulation.
The delay of recovery after anesthesia was mainly caused by the use of anesthetic drugs during the perioperative period. The drugs commonly used during the perioperative period are opioid analgesics, sedatives and muscle relaxants. Studies have shown that intravenous opioids are more difficult to control than neuromuscular relaxants. Opioids can extend the recovery time after anesthesia by direct sedation of opioid receptors. It also reduces the sensitivity of brainstem chemoreceptors to carbon dioxide, leading to dose-dependent respiratory depression and hypercapnia, which affects the removal of volatile substances and carbon dioxide, and ultimately leads to coma. In addition, the active metabolites of some opioids can prolong the duration of action, especially in the case of impaired renal function, which can lead to delayed awakening.
As an opioid antagonist, nalmefene can inhibit or reverse the respiratory inhibition, sedation and hypotension effects of opioid drugs. Moreover, it has no opioid excitatory activity, does not produce respiratory inhibition, hallucinogenic effect or pupil dilation. In terms of inducing wakefulness during anesthesia, nalmefene can effectively reverse the sedative effect caused by opioids. There have been reports at home and abroad that nalmefene can be used to improve the effect of post-anesthesia resuscitation and reduce agitation during the waking period, but there is still a lack of large sample and well-designed randomized controlled studies to provide important data on how to improve the quality of anesthetized resuscitation. This study will conduct a rigorous randomized controlled studies,with large sample, and the research indicators for patients from the PACU roll-out to ordinary ward, using Aldrete score , in order to obtain a series of data of nalmefene used for anesthesia recovery , and to set the foundation of related research of nalmefene and similar drugs in clinical application in the future.
Read the detailed description
Postoperative recovery is an important part of the patient's experience, regardless of the type of surgery. The recovery and prognosis of postoperative anesthesia have gradually become important indicators for judging the efficacy and quality of anesthesia. The recovery period of general anesthesia is an important transition period from anesthesia to wakefulness, and a good recovery period is an important guarantee for the recovery of postoperative organs and functions after surgery. However, the delay in awakening after general anesthesia remains one of the biggest challenges facing anesthesiologists. Postoperative resuscitation is the result of the removal of anesthetics from the brain. The time of resuscitation depends on patient factors, effects of anesthetic factors, duration of surgery, and painful stimulation.
The delay of recovery after anesthesia was mainly caused by the use of anesthetic drugs during the perioperative period. The drugs commonly used during the perioperative period are opioid analgesics, sedatives and muscle relaxants. Studies have shown that intravenous opioids are more difficult to control than neuromuscular relaxants. Opioids can extend the recovery time after anesthesia by direct sedation of opioid receptors. It also reduces the sensitivity of brainstem chemoreceptors to carbon dioxide, leading to dose-dependent respiratory depression and hypercapnia, which affects the removal of volatile substances and carbon dioxide, and ultimately leads to coma. In addition, the active metabolites of some opioids can prolong the duration of action, especially in the case of impaired renal function, which can lead to delayed awakening.
As an opioid antagonist, nalmefene can inhibit or reverse the respiratory inhibition, sedation and hypotension effects of opioid drugs. Moreover, it has no opioid excitatory activity, does not produce respiratory inhibition, hallucinogenic effect or pupil dilation. No pharmacological effects were observed without the administration of opioid agonists. In terms of inducing wakefulness during anesthesia, nalmefene can effectively reverse the sedative effect caused by opioids. There have been reports at home and abroad that nalmefene can be used to improve the effect of post-anesthesia resuscitation and reduce agitation during the waking period, but there is still a lack of large sample and well-designed randomized controlled studies to provide important data on how to improve the quality of anesthetized resuscitation. In order to speed up the awakening after anesthesia, promote the patients' consciousness and respiratory recovery, and improve the quality of awakening patients after anesthesia, the patients should control postoperative pain immediatly, improve the comfort of patients in the PACU, reduce the residence time of patients, speed up the circulation of operated patients, reduce the costs of PACU, and reduce the staff workload in the PACU. This study will conduct a rigorous randomized controlled studies, large sample, and the research indicators for patients from the PACU roll-out to ordinary ward, using Aldrete score , in order to obtain a series of data of nalmefene used for anesthesia recovery , and to lay the foundation of related research of nalmefene and similar drugs in clinical application in the future.
- Conditions
- Resuscitation
- Being tested
- Nalmefene, normal Saline
- Keywords
- nalmefene, quality of resuscitation, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalmefeneDrug
Immediately Intravenous injection of Nalmefene (0.25 g/kg, plus normal saline to 1ml) after surgery
normal SalineDrug
Immediately Intravenous injection of normal saline 1ml after surgery
| Study group | Role | What they receive |
|---|---|---|
| Nalmefene group | Experimental | for the nalmefene group, immediately Intravenous injection of Nalmefene (0.25 g/kg, plus normal saline to 1ml) after surgery Receives: Drug: Nalmefene |
| Control group | Placebo comparator | Intravenous injection of normal saline 1ml immediately after surgery Receives: Drug: normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time stay in PACU
The time between the end of the operation and the Aldrete score ≥9 in PACU
Measured: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
Secondary outcomes (8)
Extube time
The time from the end of the operation to the removal of the endotracheal tube in PACU
Measured: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
RASS score
RASS score when the removal of the endotracheal tube
Measured: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
the directional force The time at which the Montreal orientation score was ≥5
The time at which the Montreal orientation score was ≥5
Measured: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
Whether to use remedial analgesic drug (sufentanil) in PACU and the dosage
Whether to use remedial analgesic drug (fentanyl) in PACU and the dosage in PACU
Measured: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
VAS pain score (assessment time Aldrete score ≥9 points, 1h after surgery, 24h after surgery)
VAS pain score (assessment time Aldrete score ≥9 points, 1h after surgery, 24h after surgery) with assessment time Aldrete score ≥9 points, 1h after surgery, 24h after surgery)
Measured: 1h after surgery, and 24h after surgery
The incidence of nausea and vomiting in PACU
The incidence of nausea and vomiting in PACU
Measured: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
Incidence of nausea and vomiting 0-24h after surgery
Incidence of nausea and vomiting 0-24h after surgery
Measured: From the end of operation up to 24h after surgery
Incidence of pruritus 0-24h after surgery
Incidence of pruritus 0-24h after surgery
Measured: From the end of operation up to 24h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start24 Sep 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tong Ren Hospital, First Affiliated Hospital of Guangxi Medical University, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
- Investigators
- Weifeng Yu, Study chair, Department of Anesthesiology, Renji Hospital, School of Medicine, SJTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713358
- Sponsor's protocol ID
- 2020-sx004
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2020
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma X, Liu J, Zhang Y, Li L, Zhang G, Xing L, Huai X, Tang Y, Xie Y, Su D. Efficacy of low-dose nalmefene on recovery from general anaesthesia in adult patients: a multicentre randomised controlled study. BMJ Open. 2026 Mar 10;16(3):e107754. doi: 10.1136/bmjopen-2025-107754.
PubMed 41807006Ma X, Liu J, Tang Y, Lian Q, Huai X, Liu W, Su D. The efficacy of nalmefene on anesthetic recovery of patients: a study protocol for a multicenter randomized controlled trial. Trials. 2023 Mar 1;24(1):156. doi: 10.1186/s13063-023-07169-4.
PubMed 36859316
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04713358
- Acronym / sponsor ID
- 2020-sx004
- Conditions
- Resuscitation
- Keywords
- nalmefene, quality of resuscitation, general anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Tong Ren Hospital, First Affiliated Hospital of Guangxi Medical University, The First Affiliated Hospital of Zhengzhou University
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative recovery is an important part of the patient's experience. A good recovery period is an important guarantee for the recovery of postoperative organs and functions after surgery. However, the delay in awakening after general anesthesia remains one of the biggest challenges facing anesthesiologists. The time of resuscitation depends on patient factors, effects of anesthetic factors, duration of surgery, and painful stimulation.
The delay of recovery after anesthesia was mainly caused by the use of anesthetic drugs during the perioperative period. The drugs commonly used during the perioperative period are opioid analgesics, sedatives and muscle relaxants. Studies have shown that intravenous opioids are more difficult to control than neuromuscular relaxants. Opioids can extend the recovery time after anesthesia by direct sedation of opioid receptors. It also reduces the sensitivity of brainstem chemoreceptors to carbon dioxide, leading to dose-dependent respiratory depression and hypercapnia, which affects the removal of volatile substances and carbon dioxide, and ultimately leads to coma. In addition, the active metabolites of some opioids can prolong the duration of action, especially in the case of impaired renal function, which can lead to delayed awakening.
As an opioid antagonist, nalmefene can inhibit or reverse the respiratory inhibition, sedation and hypotension effects of opioid drugs. Moreover, it has no opioid excitatory activity, does not produce respiratory inhibition, hallucinogenic effect or pupil dilation. In terms of inducing wakefulness during anesthesia, nalmefene can effectively reverse the sedative effect caused by opioids. There have been reports at home and abroad that nalmefene can be used to improve the effect of post-anesthesia resuscitation and reduce agitation during the waking period, but there is still a lack of large sample and well-designed randomized controlled studies to provide important data on how to improve the quality of anesthetized resuscitation. This study will conduct a rigorous randomized controlled studies,with large sample, and the research indicators for patients from the PACU roll-out to ordinary ward, using Aldrete score , in order to obtain a series of data of nalmefene used for anesthesia recovery , and to set the foundation of related research of nalmefene and similar drugs in clinical application in the future.
Detailed description
Postoperative recovery is an important part of the patient's experience, regardless of the type of surgery. The recovery and prognosis of postoperative anesthesia have gradually become important indicators for judging the efficacy and quality of anesthesia. The recovery period of general anesthesia is an important transition period from anesthesia to wakefulness, and a good recovery period is an important guarantee for the recovery of postoperative organs and functions after surgery. However, the delay in awakening after general anesthesia remains one of the biggest challenges facing anesthesiologists. Postoperative resuscitation is the result of the removal of anesthetics from the brain. The time of resuscitation depends on patient factors, effects of anesthetic factors, duration of surgery, and painful stimulation.
The delay of recovery after anesthesia was mainly caused by the use of anesthetic drugs during the perioperative period. The drugs commonly used during the perioperative period are opioid analgesics, sedatives and muscle relaxants. Studies have shown that intravenous opioids are more difficult to control than neuromuscular relaxants. Opioids can extend the recovery time after anesthesia by direct sedation of opioid receptors. It also reduces the sensitivity of brainstem chemoreceptors to carbon dioxide, leading to dose-dependent respiratory depression and hypercapnia, which affects the removal of volatile substances and carbon dioxide, and ultimately leads to coma. In addition, the active metabolites of some opioids can prolong the duration of action, especially in the case of impaired renal function, which can lead to delayed awakening.
As an opioid antagonist, nalmefene can inhibit or reverse the respiratory inhibition, sedation and hypotension effects of opioid drugs. Moreover, it has no opioid excitatory activity, does not produce respiratory inhibition, hallucinogenic effect or pupil dilation. No pharmacological effects were observed without the administration of opioid agonists. In terms of inducing wakefulness during anesthesia, nalmefene can effectively reverse the sedative effect caused by opioids. There have been reports at home and abroad that nalmefene can be used to improve the effect of post-anesthesia resuscitation and reduce agitation during the waking period, but there is still a lack of large sample and well-designed randomized controlled studies to provide important data on how to improve the quality of anesthetized resuscitation. In order to speed up the awakening after anesthesia, promote the patients' consciousness and respiratory recovery, and improve the quality of awakening patients after anesthesia, the patients should control postoperative pain immediatly, improve the comfort of patients in the PACU, reduce the residence time of patients, speed up the circulation of operated patients, reduce the costs of PACU, and reduce the staff workload in the PACU. This study will conduct a rigorous randomized controlled studies, large sample, and the research indicators for patients from the PACU roll-out to ordinary ward, using Aldrete score , in order to obtain a series of data of nalmefene used for anesthesia recovery , and to lay the foundation of related research of nalmefene and similar drugs in clinical application in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalmefene group | Experimental | Drug: Nalmefenefor the nalmefene group, immediately Intravenous injection of Nalmefene (0.25 g/kg, plus normal saline to 1ml) after surgery |
| Control group | Placebo comparator | Drug: normal SalineIntravenous injection of normal saline 1ml immediately after surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age is greater than or equal to 18 years old and less than 65 years old
- Patients who need tracheal intubation under general anesthesia at the right time for orthopedics, urology, and thoracic elective surgery
- Patients with American Society of Anesthesia physical status I or II
- BMI≥18kg/m2, and ≤30kg/m2
- The estimated anesthesia time is 1-4 hours.
Key exclusion criteria (13 listed)
- patients who refused to participate in the study
- pantients who refuse intravenous analgesia
- medical history or family history of cognitive disorders,delirium, epilepsy, abalienation, anxiety or depression;
- recent use of anticholinergic drugs, antidepressants, antianxietics or anticonvulsants
- medical history of organic brain diseases or cranial vascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NalmefeneImmediately Intravenous injection of Nalmefene (0.25 g/kg, plus normal saline to 1ml) after surgery | Drug | Nalmefene group |
| normal SalineImmediately Intravenous injection of normal saline 1ml after surgery | Drug | Control group |
Primary outcome
Time stay in PACU
Time frame: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
The time between the end of the operation and the Aldrete score ≥9 in PACU
8 secondary outcomes
Extube time
Time frame: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
RASS score
Time frame: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
the directional force The time at which the Montreal orientation score was ≥5
Time frame: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
Whether to use remedial analgesic drug (sufentanil) in PACU and the dosage
Time frame: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
VAS pain score (assessment time Aldrete score ≥9 points, 1h after surgery, 24h after surgery)
Time frame: 1h after surgery, and 24h after surgery
The incidence of nausea and vomiting in PACU
Time frame: From the end of the operation to the time that patient leave to inpatient ward up to 2hours
Incidence of nausea and vomiting 0-24h after surgery
Time frame: From the end of operation up to 24h after surgery
Incidence of pruritus 0-24h after surgery
Time frame: From the end of operation up to 24h after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Derived from this study: PubMed 41807006Ma X, Liu J, Zhang Y, Li L, Zhang G, Xing L, Huai X, Tang Y, Xie Y, Su D. Efficacy of low-dose nalmefene on recovery from general anaesthesia in adult patients: a multicentre randomised controlled study. BMJ Open. 2026 Mar 10;16(3):e107754. doi: 10.1136/bmjopen-2025-107754.
- Derived from this study: PubMed 36859316Ma X, Liu J, Tang Y, Lian Q, Huai X, Liu W, Su D. The efficacy of nalmefene on anesthetic recovery of patients: a study protocol for a multicenter randomized controlled trial. Trials. 2023 Mar 1;24(1):156. doi: 10.1186/s13063-023-07169-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weifeng Yu study chair
Department of Anesthesiology, Renji Hospital, School of Medicine, SJTU
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalmefene and normal Saline in people with Resuscitation, run by RenJi Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time stay in PACU (time frame: From the end of the operation to the time that patient leave to inpatient ward up to 2hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04713358, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.