Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
RenJi Hospital
Collaborators:
First Affiliated Hospital of Guangxi Medical University Renmin Hospital of Wuhan University Shanghai Tong Ren Hospital The First Affiliated Hospital of Zhengzhou University