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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05184959
Other study ID # 2021-1069
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date December 1, 2022

Study information

Verified date December 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

High-dose benzodiazepines can inhibit the central nervous system, respiratory system and cardiovascular motor center, resulting in loss of consciousness, disappearance of reflex, respiratory inhibition, decrease of blood pressure and so on. This kind of drug acute poisoning is the most common drug poisoning in internal medicine. It has acute onset and severe symptoms. If it is not treated properly in time, it can be life-threatening. At present, the research on the accumulation and metabolic state caused by benzodiazepine poisoning is not sufficient; at the same time, the changes of neuroendocrine metabolism and immune function of patients with neuroendocrine metabolism and immune function need to be further explored. Therefore, the main purpose of this study is to analyze the effects of neuroendocrine metabolism and immune function on organ function and mental state in patients with benzodiazepine poisoning.


Description:

Benzodiazepines are the first choice for clinical anti-anxiety, sedation and hypnosis, as well as anticonvulsant, antiepileptic and central muscle relaxation. Commonly used are diazepam (diazepam), nitro diazepam, clonazepam, alprazolam, triazolam and so on. The drug itself is an inhibitor of the central nervous system, which has a high selectivity for the inhibition of the central nervous system, mainly inhibiting the limbic system of the brain and less inhibitory effect on the reticular ascending activation system. It mainly acts on the synaptic sites of GABA-Ergic nerve endings in the central nervous system. It enhances the affinity between GABA and its receptors by binding to benzodiazepine receptors, thus increasing the open frequency of Cl- channels coupled with GABA receptors and exerting an inhibitory effect. High-dose benzodiazepines can inhibit the central nervous system, respiratory system and cardiovascular motor center, resulting in loss of consciousness, disappearance of reflex, respiratory inhibition, decrease of blood pressure and so on. This kind of drug acute poisoning is the most common drug poisoning in internal medicine. It has acute onset and severe symptoms. If it is not treated properly in time, it can be life-threatening. At present, the research on the accumulation and metabolic state caused by benzodiazepine poisoning is not sufficient; at the same time, the changes of neuroendocrine metabolism and immune function of patients with neuroendocrine metabolism and immune function need to be further explored. Therefore, the main purpose of this study is to analyze the effects of neuroendocrine metabolism and immune function on organ function and mental state in patients with benzodiazepine poisoning.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Benzodiazepine poisoning Within 6 hours, at least one target organ dysfunction. No bad habits (drug use, alcohol addiction) Exclusion Criteria: Refusal to join this study Lack of information/incompleteness Vulnerable groups such as pregnant women, incapable of civil conduct and indeterminate agent consent Chronic multiple organ dysfunction Tumors, blood system diseases, various systemic immune diseases Various infectious diseases (various hepatitis, tuberculosis, AIDS)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type Measure Description Time frame Safety issue
Primary Time interval Interval from benzodiazepine poisoning to emergency pre-examination at admittion
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