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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02984839
Enrollment
120
Registered
2016-12-07
Start date
2016-11-30
Completion date
2017-05-16
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade, Pulmonary Complication

Keywords

intra-abdominal surgery, neuromuscular blocking agent, post-anesthesia care unit

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 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 (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.

Interventions

DEVICEStimpod NMS450® Nerve Stimulator, by Xavant™ Technology

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

Sponsors

OhioHealth
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Train-of-four (TOF) ratio15 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

MeasureTime frameDescription
Need for supplemental O2 therapy30 minutes post arrival in the PACUNecessity for supplemental O2 therapy after 30 minutes in PACU will be recorded via chart review to determine post operative pulmonary complication

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026