Incidence of Postoperative Neuromuscular Blockade in Post-Anesthesia Care Unit at Parkland Hospital: Does Size Matter?

Incidence of Postoperative Neuromuscular Blockade in the Post-Anesthesia Care Unit at Parkland Hospital: Does Size Matter?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03111082

Enrollment

100

Registered

2017-04-12

Start date

2017-07-11

Completion date

2018-04-16

Last updated

2018-04-25

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

Conditions

Residual Neuromuscular Blockade

Brief summary

This prospective, observational study will assess 100 subjects in the post-anesthesia care unit (PACU) at Parkland Hospital. Upon arrival to the PACU, patients' train-of-four (TOF) ratio will be calculated using the StimPod NMS450 accelerometer to determine the presence of any residual paralysis. Any patient with a TOF ratio \< 0.9 will be reassessed every 10 minutes until the ratio is ≥0.90. The time it takes to reach a TOF ratio ≥0.9 will be recorded. Subjects will be classified according to BMI categories: lean as \<30 kg/m2, obese as 30≤BMI≤39.9 kg/m2, and morbidly obese as BMI ≥40 kg/m2. This data will serve as a baseline to assess the incidence of residual NMB that currently occurs in our PACU so that we may use this pilot data to design future studies that aim to reduce the incidence of residual NMB.

Detailed description

Upon arrival to the PACU, patients enrolled in the study will be evaluated for residual paralysis with train-of-four (TOF) stimulation using the StimPod NMS450 accelerometer set to 30 mA. Any patients who have residual paralysis will be assessed Q10 minutes until the TOF ratio is ≥0.9. The time to achieve a TOF ratio ≥0.9 will be recorded. Any adverse events (e.g., hypoxia, reintubation, aspiration) that arise during the patient's PACU stay will be documented.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 18-80 years old * Undergoing non-emergent surgery with general endotracheal anesthesia * ASA physical status classification 1 to 4 * Willing and able to consent in English or Spanish * No personal history of neuromuscular disease

Exclusion criteria

* Age less than 18 or older than 80 * Patient does not speak English or Spanish * Planned postoperative intubation or ICU admission * Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium * Family or personal history of malignant hyperthermia * Patient refusal * Monitored anesthesia care (MAC) or regional anesthesia planned * Pregnant or nursing women * Stat (emergent) cases * Estimated creatinine clearance \<30 mL/min * Pre-existing muscle weakness of any etiology

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Residual Neuromuscular Blockade	1 day on arrival to PACU	To establish the current incidence of postoperative residual neuromuscular blockade (NMB), defined as a train-of-four ratio \<0.9, in patients upon arrival to the PACU.

Secondary

Measure	Time frame	Description
Comparison of RNMB in Lean, Obese, and Morbidly Obese Patients	1 day on arrival to PACU	To assess the differences in the incidence of postoperative residual neuromuscular blockade (NMB) among PACU patients categorized based on body mass index (BMI) (lean, obese, and morbidly obese).

Countries

United States

Outcome results