Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136585
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-11-13
Brief Title:
Sugammadex Vs Neostigmine in Reversing Neuromuscular Blocks in Outpatient ERCP A Randomized Double-Blinded Trial
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Comparison of Efficacy of Sugammadex Versus Neostigmine in Reversing Neuromuscular Blocks in Patients Having Outpatient Endoscopic Retrograde Cholangiopancreatography ERCP A Randomized Double-Blinded Trial
Status:
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:
None
Brief Summary:
The investigators propose a single-centerassessor-Blinded parallel group randomized trial to compare the efficacy of reversal of rocuronium induced neuromuscular blockade by sugammadex versus neostigmine in patients undergoing Endoscopic retrograde cholangiopancreatography at Cleveland Clinic Main Campus
Detailed Description:
The investigators propose a single-center assessor-blinded parallel group randomized trial to compare the efficacy of reversal of rocuronium induced neuromuscular blockade by sugammadex versus neostigmine Participating patients and outcome assessors will be blinded to group assignment The anesthesiologists who assume anesthesia care will not be blinded to group assignment
American Society of Anesthesiologists ASA physical status 3 and 4 adults scheduled for elective outpatient ERCP procedure with general anesthesia at Cleveland Clinic Main Campus will be included in the study Patients will be excluded if they have suspected difficult airway neuromuscular disorders end-stage renal disease requiring hemodialysis are allergic to fentanyl neuromuscular blocking drugs or neuromuscular reversal drugs or are pregnant or breastfeeding
Eighty patients scheduled for outpatient ERCP with general anesthesia and rocuronium-induced muscle relaxation will be randomized 11 to 1 reversal by sugammadex or 2 reversal by neostigmine Randomization will be stratified by 2 factors 1 patients age older than 60 versus younger than 60 and 2 diagnostic vs interventional procedures Randomization will be based on computer generated codes that will be maintained in web-based system until shortly before induction of anesthesia thus concealing allocation so long as practical
American Society of Anesthesiologists ASA physical status 3 and 4 adults scheduled for elective outpatient ERCP procedure with general anesthesia at Cleveland Clinic Main Campus will be included in the study Patients will be excluded if they have suspected difficult airway neuromuscular disorders end-stage renal disease requiring hemodialysis are allergic to fentanyl neuromuscular blocking drugs or neuromuscular reversal drugs or are pregnant or breastfeeding
Eighty patients scheduled for outpatient ERCP with general anesthesia and rocuronium-induced muscle relaxation will be randomized 11 to 1 reversal by sugammadex or 2 reversal by neostigmine Randomization will be stratified by 2 factors 1 patients age older than 60 versus younger than 60 and 2 diagnostic vs interventional procedures Randomization will be based on computer generated codes that will be maintained in web-based system until shortly before induction of anesthesia thus concealing allocation so long as practical
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?:
False
Is an FDA AA801 Violation?:
None