Clinical trial NCT04713358: Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia
Official title: Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia
Conditions: Resuscitation
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.
Interventions:
description: Immediately Intravenous injection of Nalmefene (0.25 g/kg, plus normal saline to 1ml) after surgery
name: Nalmefene
type: Drug
description: Immediately Intravenous injection of normal saline 1ml after surgery
name: normal Saline
type: Drug
Study arms:
design_group_description: for the nalmefene group, immediately Intravenous injection of Nalmefene (0.25 g/kg, plus normal saline to 1ml) after surgery
design_group_title: Nalmefene group
design_group_type: Experimental
design_group_description: Intravenous injection of normal saline 1ml immediately after surgery
design_group_title: Control group
design_group_type: Placebo Comparator
Sponsor: Shanghai Renji Hospital Management Co., Ltd.
Collaborators: The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Guangxi Medical University
Drug name mappings:
name: 盐酸纳美芬
lang: CN
name: Nalmefene Hydrochloride
lang: EN
name: ナルメフェン塩酸塩水和物
lang: JP