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

Completed

• Conditions: Residual Neuromuscular Blockade

• Registration Number: NCT03111082
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-12
• Study Start: 2017-07-11
• Primary Completion: 2018-01-16
• Status Verified: 2018-04
• Study Completion: 2018-04-16
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Parkland Health & Hospital System; 🇺🇸 Dallas, Texas, United States