Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia

NCT04713358 | Completed Phase 4

• 1 other identifier: 2020-sx004
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Resuscitation

Keywords

nalmefene; quality of resuscitation; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Time stay in PACU

  The time between the end of the operation and the Aldrete score ≥9 in PACU

  From the end of the operation to the time that patient leave to inpatient ward up to 2hours

Secondary Outcomes (8)

• Extube time

  From the end of the operation to the time that patient leave to inpatient ward up to 2hours

• RASS score

  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

  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

  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)

  1h after surgery, and 24h after surgery

Study Arms (2)

Nalmefene group

EXPERIMENTAL

for the nalmefene group, immediately Intravenous injection of Nalmefene (0.25 g/kg, plus normal saline to 1ml) after surgery

Drug: Nalmefene

Control group

PLACEBO COMPARATOR

Intravenous injection of normal saline 1ml immediately after surgery

Drug: normal Saline

Interventions

Nalmefene DRUG

Immediately Intravenous injection of Nalmefene (0.25 g/kg, plus normal saline to 1ml) after surgery

Nalmefene group

normal Saline DRUG

Immediately Intravenous injection of normal saline 1ml after surgery

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: collaborator
• RenJi Hospital: lead
• Shanghai Tong Ren Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (4)

The First Affiliated Hospital of Guangxi Medical University

Guangxi, Guangxi, 530000, China

Location

Shanghai Tong Ren Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

The First Affiliated Hospital of Zhengzhou University

Henan, Zhengzhou, 450000, China

Location

Related Publications (2)

• 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.

  PMID: 41807006 DERIVED

• Ma 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.

  PMID: 36859316 DERIVED

MeSH Terms

Interventions

nalmefene; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Weifeng Yu

  Department of Anesthesiology, Renji Hospital, School of Medicine, SJTU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 19, 2021
• Study Start: September 24, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CN (4)