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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuromuscular Blockade Pulmonary Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OhioHealth Doctors Hospital

Columbus, Ohio, 43228, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology

Device

Quantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

OhioHealth

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Dec 7, 2016
Registry last updated: Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed