Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05649020
Status:
RECRUITING
Last Update Posted:
2022-12-13
First Post:
2022-11-30
Brief Title:
ED50 of Intratecal Prilocaine in Ultrasound Fusion Prostate Biopsy
Sponsor:
Hospital General Universitario Gregorio Marañon
Organization:
Hospital General Universitario Gregorio Marañon
Study Overview
Official Title:
ED50 of Intrathecal Hyperbaric 2 Prilocaine in Transperineal Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Guided Biopsy
Status:
RECRUITING
Status Verified Date:
2022-11
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 aim of the present study was to determine the ED50 and ED90 of intrathecal hyperbaric 2 prilocaine HP for patients undergoing ambulatory prostate biopsy via magnetic resonance imaging MRIultrasound fusion
Detailed Description:
Prostate biopsy to diagnose or exclude cancer is currently performed an estimated one million times annually worldwide In this method the operator images the prostate using ultrasound as performed for the past several decades while thus viewing the prostate the MRI of that prostate which is performed beforehand and stored in the device is fused with real-time ultrasound using a digital overlay allowing the targets previously delineated by a radiologist to be brought into the aiming mechanism of the ultrasound machine The fusion results in creation of a three-dimensional reconstruction of the prostate and on the reconstructed model the aiming and tracking of biopsy sites occurs This method needs for sedationgeneral spinal anesthesia because of patient discomfort with the transperineal approach of the biopsy needle passing through the perineum
Even though the MRIultrasound fusión prostate biopsy is widespread used the anaesthetic techniques for this procedure are not standardised Hyperbaric prilocaine is an amide-type local anesthetic widely used in short surgical procedures showing its efficacy for outpatient surgery The proposed intrathecal doses of prilocaine for various surgical procedures range from 10 to 80 mg Thus even though the drug is in clinical use optimal doses of HP required for specific types of surgery warrant further refinement The aim of the present study was to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRIultrasound fusión prostate biopsy
Even though the MRIultrasound fusión prostate biopsy is widespread used the anaesthetic techniques for this procedure are not standardised Hyperbaric prilocaine is an amide-type local anesthetic widely used in short surgical procedures showing its efficacy for outpatient surgery The proposed intrathecal doses of prilocaine for various surgical procedures range from 10 to 80 mg Thus even though the drug is in clinical use optimal doses of HP required for specific types of surgery warrant further refinement The aim of the present study was to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRIultrasound fusión prostate biopsy
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