Residual Neuromuscular BlockadeNCT03111082
Incidence of Postoperative Neuromuscular Blockade in Post-Anesthesia Care Unit at Parkland Hospital: Does Size Matter?
An observational study of Residual Neuromuscular Blockade, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Residual Neuromuscular Blockade
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2017to 16 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects in the post-anesthesia care unit who have undergone surgery with neuromuscular blockade
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health & Hospital System
Dallas, Texas, 75211
About this study
Official title: Incidence of Postoperative Neuromuscular Blockade in the Post-Anesthesia Care Unit at Parkland Hospital: Does Size Matter?
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.
Read the 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
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day on arrival to PACU
Secondary outcomes (1)
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).
Measured: 1 day on arrival to PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start11 Jul 2017
- Primary completion16 Jan 2018
- Study completion16 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Moon, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111082
- Sponsor's protocol ID
- STU 032017-054
- Status last verified
- Apr 2018
- First submitted
- 7 Apr 2017
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Neuromuscular Blockade in the Post-Anesthesia Care Unit at Parkland Hospital: Does Size Matter?
- ClinicalTrials.gov ID
- NCT03111082
- Acronym / sponsor ID
- STU 032017-054
- Conditions
- Residual Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects in the post-anesthesia care unit who have undergone surgery with neuromuscular blockade
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Residual Neuromuscular Blockade
Time frame: 1 day on arrival to PACU
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 secondary outcome
Comparison of RNMB in Lean, Obese, and Morbidly Obese Patients
Time frame: 1 day on arrival to PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Residual Neuromuscular Blockade
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
Not yet recruitingObservational study
Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
Postoperative Residual Curarization, Neuromuscular Block Prolonged
Not yet recruitingObservational study
Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery
Neuromuscular Blockade, Cholecystectomy
Recruiting
Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function
Residual Neuromuscular Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Moon, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Residual Neuromuscular Blockade, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Residual Neuromuscular Blockade (time frame: 1 day on arrival to PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.