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

NCT ID: NCT03111082

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2018-04-16

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.

Conditions

Residual Neuromuscular Blockade

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lean

BMI less than or equal to 29.9

No interventions assigned to this group

Obese

BMI between 30.0 and 39.9

No interventions assigned to this group

Morbidly Obese

BMI greater than or equal to 40.0

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiffany Moon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Parkland Health & Hospital System

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 032017-054

Identifier Type: -

Identifier Source: org_study_id