Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451380
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-04
Brief Title:
Patient-controlled Sedation With Propofol Versus Anesthesiologist-administered Sedation for Orthopedic Surgery
Sponsor:
GCS Ramsay Santé pour lEnseignement et la Recherche
Organization:
GCS Ramsay Santé pour lEnseignement et la Recherche
Study Overview
Official Title:
Patient-controlled Sedation With Propofol Versus Anesthesiologist-administered Sedation for Orthopedic Surgery Under Regional Anesthesia a Prospective Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
PACOSA
Brief Summary:
The purpose of this study is to compare patient satisfaction with patient-controlled sedation with propofol and anesthesiologist-controlled sedation during orthopedic procedures of the upper limb under locoregional anesthesia
Detailed Description:
This is an interventional prospective randomized open-label controlled single-center study designed to evaluate the less commonly used patient-controlled sedation comparing it with sedation administered by the anesthesiologist in a population of patients indicated for orthopedic upper limb surgery requiring additional sedation
Once informed consent has been signed patients will be randomized into one of two study arms in a 11 ratio stratified by age
Experimental arm 1 patient-controlled propofol sedation
Control arm 2 anesthesiologist-controlled propofol sedation
Patient participation in the study lasts from 1 to 7 days maximum from preoperative inclusion to hospital discharge
Once informed consent has been signed patients will be randomized into one of two study arms in a 11 ratio stratified by age
Experimental arm 1 patient-controlled propofol sedation
Control arm 2 anesthesiologist-controlled propofol sedation
Patient participation in the study lasts from 1 to 7 days maximum from preoperative inclusion to hospital discharge
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