Incidence of Postoperative Neuromuscular Blockade in Post... | NCT03111082

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

NCT03111082

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

Apr 25, 2018Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Residual Neuromuscular Blockade

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2017Actual

Primary Completion Date

Jan 16, 2018Actual

Completion Date

Apr 16, 2018Actual

First Submitted Date

Apr 7, 2017

First Submission Date that Met QC Criteria

Apr 11, 2017

First Posted Date

Apr 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2018

Last Update Posted Date

Apr 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tiffany Moon, MD	University of Texas Southwestern Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parkland Health & Hospital System		Dallas	Texas	75211	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055191	Delayed Emergence from Anesthesia

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided