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

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.

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Key information

Conditions

Residual Neuromuscular Blockade Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkland Health & Hospital System

Dallas, Texas, 75211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

Incidence of Residual Neuromuscular Blockade

Time frame: 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 outcomes

Comparison of RNMB in Lean, Obese, and Morbidly Obese Patients

Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Apr 12, 2017
Registry last updated: Apr 25, 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.

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