Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05040490
Status:
UNKNOWN
Last Update Posted:
2021-09-10
First Post:
2021-08-25
Brief Title:
Influence of Neostigmine vs Sugammadex on PORC and PPCs by Ultrasonography
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Comparison of the Effects of Neostigmine and Sugammadex on Postoperative Residual Curarization and Postoperative Pulmonary Complications Detected by Diaphragm and Lung Ultrasonography A Study Protocol for Prospective Double-blind Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
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:
This trial aims to compare the incidence of postoperative residual curarisation PORC and postoperative pulmonary complications PPCs in the SUG and NEO group by means of diaphragm ultrasonography and LUS so as to conclude whether SUG can outperform NEO in preventing occurrence of PORC and PPCs
Detailed Description:
The incidence of postoperative residual curarisation PORC is about 2-64 worldwide which may be an underling risk factor of postoperative pulmonary complications PPCs causing many undesirable effects on patients Thus reversal drugs of neuromuscular blocking agents NMBAs such as neostigmine NEO and sugammadex SUG have been administrated and SUG maybe perform better in preventing PORC Different supplementary methods to help identify PORC or PPCs have also been reported such as adductor of pollicis acceleromyography and lung ultrasound LUS Recently diaphragm ultrasonography has been used to evaluate PORC as a novel approachIn this prospective double-blind randomized controlled trial we will enroll 414 patients of American Society of Anesthesiologists physical status I-III aged over 60 years who will be scheduled to undergo arthroplasty surgery under general anesthesia Participants will be randomized into NEO and SUG group receiving neostigmine and sugammadex as reversal drug respectively The primary outcomes will be the incidence of PPCs in NEO and SUG group respectively The secondary outcome is the incidence of PORC in the two groupsWe hypothesize that 1 the incidence of PPCs is lower after reversal with SUG than with NEO 2 using the method of diaphragm ultrasonography the incidence PORC is lower after reversal with SUG than with NEO 3 the incidence of PPCs can be predicted by LUS and by evaluating whether there is PORC through diaphragmatic ultrasound
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