Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376058
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-17
Brief Title:
Chloroprocaine 1 Versus Ropivacaine 075 During Cesarean Section
Sponsor:
Aretaieion University Hospital
Organization:
Aretaieion University Hospital
Study Overview
Official Title:
Intrathecal Use of Chloroprocaine 1 and Ropivacaine 075 During Elective Cesarean Section A Comparative Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
annie-mariana
Brief Summary:
This will be a prospective randomized study aiming at comparing an intrathecal fixed dose of chloroprocaine 1 versus an intrathecal fixed dose of ropivacaine 075 in elective cesarean sections
Detailed Description:
Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice with a definitive superiority as compared to general anesthesia since by their use serious complications involving the airway can be avoided Combined spinal-epidural anesthesia has become the favorable technique for both elective and emergency cesarean sections Various local anesthetics have been used but ropivacaine is the drug of choice in most hospitals in Greece However chloroprocaine is a preferable local anesthetic in USA due to its quick and predictable onset of action Chloroprocaine was initially used in 1980 but it became obsolete in those years due to neurological symptoms associated with its use caused mainly by the presence of sodium bisulfite and disodium ethylenediaminetetraacetate EDTA in the early formulations Nowadays new formulations of the drug without EDTA makes chloroprocaine safe for use
The aim of the current randomized controlled trial will be to compare the effect of an intrathecal fixed dose of chloroprocaine versus an intrathecal fixed dose of ropivacaine in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia
The aim of the current randomized controlled trial will be to compare the effect of an intrathecal fixed dose of chloroprocaine versus an intrathecal fixed dose of ropivacaine in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None