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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03111082
Other study ID # STU 032017-054
Secondary ID
Status Completed
Phase
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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