Clinical Trial: Incidence of Residual Neuromuscular Blockade in Intra-abdominal Surgery: A Prospective, Observational Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Incidence of Residual Neuromuscular Blockade in Intra-abdominal Surgery: A Prospective, Observational Study

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 noncardiac/non 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 complications.Although 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 use.This 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 Summary:

Residual paralysis from non-depolarizing neuromuscular blocking agents (NMBAs) is a common problem that contributes to adverse outcomes in the post-anesthesia care unit (PACU).Unidentified residual neuromuscular blockade (defined as a train-of-four (TOF) ratio <0.9) has been reported in up to 30-42% of patients in the recovery room.Though 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 used.There 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.


Sponsor: OhioHealth

Current Primary Outcome: Train-of-four (TOF) ratio [ Time Frame: 15 minutes post arrival in the post anesthesia care unit (PACU) ]

Average TOF ratio will be calculated from two consecutive readings using the Stimpod NMS450 within 15 minutes of arrival in the PACU


Original Primary Outcome: Same as current

Current Secondary Outcome: Need for supplemental O2 therapy [ Time Frame: 30 minutes post arrival in the PACU ]

Necessity for supplemental O2 therapy after 30 minutes in PACU will be recorded via chart review to determine post operative pulmonary complication


Original Secondary Outcome: Same as current

Information By: OhioHealth

Dates:
Date Received: December 3, 2016
Date Started: November 2016
Date Completion: December 2018
Last Updated: December 6, 2016
Last Verified: December 2016