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

NCT03111082 | Completed

• 1 other identifier: STU 032017-054
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Residual Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Incidence of Residual Neuromuscular Blockade

  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.

  1 day on arrival to PACU

Secondary Outcomes (1)

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

  1 day on arrival to PACU

Study Arms (3)

Lean

BMI less than or equal to 29.9

Obese

BMI between 30.0 and 39.9

Morbidly Obese

BMI greater than or equal to 40.0

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects in the post-anesthesia care unit who have undergone surgery with neuromuscular blockade

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75211, United States

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiffany Moon, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 12, 2017
• Study Start: July 11, 2017
• Primary Completion: January 16, 2018
• Study Completion: April 16, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)