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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Neuromuscular Blockade, Pulmonary Complication

Intervention / Treatment
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* Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking ASA physical status classification I-IV Procedures requiring intubation and nondepolarizing NMBA administration Laparoscopic surgery Intra-abdominal surgery Procedures using the Da Vinci surgical system Tonsillectomy Septoplasty Shoulder surgery Total hip arthroplasty Carotid endarterectomy Cervical spine surgery Parotidectomy Thyroidectomy Aorto-bifemoral bypass Micro laryngoscopy Nasal or sinus surgery Dental extraction Exclusion Criteria: Non-English speaking population ASA V and VI Unable to give informed consent Cardiac or intra-thoracic procedures performed Severe renal insufficiency (Serum Creatinine >2.0 mg/dL) Severe hepatic dysfunction Underlying neuromuscular disease Currently enrolled in another therapeutic study Pregnant patients at any stage of pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intra-abdominal surgery group<br>The study population will include patients presenting for elective or non-elective intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital. Quantitative TOF will be recorded by Stimpod NMS450 in PACU. | Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology<br>* Quantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450<br>|
| Non-intra-abdominal surgery group<br>The study population will include patients presenting for elective or non-elective non intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital. Quantitative TOF will be recorded by Stimpod NMS450 in PACU. | Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology<br>* Quantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Train-of-four (TOF) ratio | Average TOF ratio will be calculated from two consecutive readings using the Stimpod NMS450 within 15 minutes of arrival in the PACU | 15 minutes post arrival in the post anesthesia care unit (PACU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for supplemental O2 therapy | Necessity for supplemental O2 therapy after 30 minutes in PACU will be recorded via chart review to determine post operative pulmonary complication | 30 minutes post arrival in the PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra-abdominal surgery, neuromuscular blocking agent, post-anesthesia care unit