Viewing Study NCT03642301



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Last Modification Date: 2024-10-26 @ 12:52 PM
Study NCT ID: NCT03642301
Status: COMPLETED
Last Update Posted: 2019-05-22
First Post: 2018-07-24

Brief Title: Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal Hyperbaric Prilocaine
Sponsor: Centre Hospitalier Universitaire Saint Pierre
Organization: Centre Hospitalier Universitaire Saint Pierre

Study Overview

Official Title: Dosing of Carcinogenic Complexes Such as Urinary O-toluidine and Hemoglobin Adducts From O-toluidine in Blood After Intrathecal Administration of 50 mg Hyperbaric Prilocaine
Status: COMPLETED
Status Verified Date: 2019-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The prilocaine is a very common local anesthetic that has the disadvantage of being metabolized to o-toluidine a human carcinogen

Hyperbaric 2 prilocaine HP recently developped is increasingly used for spinal anesthesia in ambulatory surgery But the formation of carcinogenic metabolites induced by the hyperbaric prilocaine is not yet known The aim of this study is to investigate whether the intrathecal administration of 50 mg hyperbaric prilocaine induces also the formation of carcinogenic complexes such as urinary o-toluidine and hemoglobin adducts from o-toluidine in blood
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None