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

Residual Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111082
• Other study ID #: STU 032017-054
• Status: Completed
• First received: April 7, 2017
• Last updated: April 23, 2018
• Start date: July 11, 2017
• Est. completion date: April 16, 2018

Study information

• Verified date: April 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 16, 2018
• Est. primary completion date: January 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Residual Neuromuscular Blockade

Locations

Country	Name	City	State
United States	Parkland Health & Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of RNMB in Lean, Obese, and Morbidly Obese Patients	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).	1 day on arrival to PACU