Ignite Creation Date:
2024-05-06 @ 9:26 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02984839
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2016-12-03
Brief Title:
Incidence of Residual Neuromuscular Blockade in Intra-abdominal Surgery A Prospective Observational Study
Sponsor:
OhioHealth
Organization:
OhioHealth
Study Overview
Official Title:
Incidence of Residual Neuromuscular Blockade in Intra-abdominal Surgery A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2018-07
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 this prospective observational study is to determine the incidence of post-operative residual neuromuscular blockade PRNB in patients undergoing intra-abdominal procedures compared to patients undergoing other noncardiacnon intra-thoracic procedures that also require non-depolarizing neuromuscular blocking agents NMBA administration As intra-abdominal surgeries are independently associated with post-operative pulmonary complications PPCs it is important to highlight other factors such as PRNB that could contribute to these complicationsAlthough it has been shown that the risk of adverse respiratory events can be reduced by intra-operative quantitative neuromuscular monitoring such monitoring is not in widespread useThis study will incorporate quantitative monitoring in the post-anesthesia care unit PACU setting by using the Stimpod NMS450 in an effort to show a disparity in the incidence of residual paralysis between these two patient populations and to emphasize the need to implement more accurate neuromuscular monitoring especially for those that are already at increased risk for respiratory complications
Detailed Description:
Residual paralysis from non-depolarizing neuromuscular blocking agents NMBAs is a common problem that contributes to adverse outcomes in the post-anesthesia care unit PACUUnidentified residual neuromuscular blockade defined as a train-of-four TOF ratio 09 has been reported in up to 30-42 of patients in the recovery roomThough current literature supports the use of quantitative monitoring of neuromuscular blockade conventional qualitative TOF count monitoring and clinical signs head lift grip strength continue to be usedThere is strong evidence that shows reduction of clinically significant post-operative residual neuromuscular blockade PRNB after implementation of quantitative monitoring Post-operative pulmonary complications PPCs are notable adverse outcomes of residual neuromuscular blockade The implementation of quantitative monitoring may be particularly beneficial to patients who are already predisposed to PPCs secondary to the site of surgery
The purpose of this study is to evaluate the incidence of PRNB with use of quantitative neuromuscular monitoring in patients undergoing intra-abdominal procedures compared to patients undergoing other surgical procedures that also require NMBA administration
The purpose of this study is to evaluate the incidence of PRNB with use of quantitative neuromuscular monitoring in patients undergoing intra-abdominal procedures compared to patients undergoing other surgical procedures that also require NMBA administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None