Monitoring for Paralysis After Anesthesia

(QUANTUM Trial)

Overseen By Mohammad Khudirat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Rocuronium

Disqualifiers: ICU patients, Emergency cases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of surgery

1032 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to monitor patients after surgery to determine which better identifies low oxygen levels. One method uses detailed tools (quantitative monitoring), while the other uses simpler ones (qualitative monitoring). The goal is to determine which method aids faster recovery after surgery. The trial seeks adults undergoing surgery with general anesthesia and a muscle relaxant called rocuronium. It excludes those already intubated before surgery or with certain medical devices or conditions. As an unphased trial, it offers patients the chance to contribute to enhancing post-surgical care and recovery methods.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these monitoring techniques are safe for surgical patients?

Studies have shown that using quantitative monitoring during surgery is safe and reduces the risk of muscle weakness afterward. For example, one study found that this monitoring significantly lowers the chances of residual muscle paralysis post-operation, meaning patients are less likely to wake up with impaired muscle function.

Another study found that quantitative monitoring enhances anesthesia safety by providing precise information on muscle activity during surgery, helping doctors ensure patients wake up as expected.

Overall, research supports that quantitative monitoring is well-tolerated and improves surgical safety by ensuring proper muscle function upon waking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial on quantitative monitoring for paralysis after anesthesia because it promises more precise and reliable results compared to the traditional qualitative approach. Unlike qualitative monitoring, which relies on subjective assessments, quantitative monitoring uses objective measurements to detect neuromuscular function, potentially reducing the risk of residual paralysis. This method could lead to safer recoveries for patients by ensuring they regain full muscle control after surgery.

What evidence suggests that this trial's monitoring methods could be effective for improving recovery after anesthesia?

Research has shown that precise monitoring during surgery can greatly reduce the risk of muscle weakness after anesthesia. In this trial, participants will be assigned to either qualitative or quantitative monitoring. Some studies have found that quantitative monitoring, which provides accurate measurements, is more effective than older methods relying on personal judgment. By offering precise measurements, quantitative monitoring aids in a fuller and quicker recovery from anesthesia. This method is becoming common because it consistently leads to better patient outcomes. ^{1 2 3 5 6}

Who Is on the Research Team?

Mehmet Turan, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for patients undergoing non-cardiothoracic surgery who will receive neuromuscular blocking agents during anesthesia. The study aims to include those interested in how different monitoring methods might affect their recovery, particularly breathing function after surgery.

Inclusion Criteria

I am 18 years old or older.

I will be put to sleep with a tube in my throat for surgery.

I have been given rocuronium for muscle relaxation.

Exclusion Criteria

Critically ill patients admitted from the ICU

Emergency cases

Non-intubated patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either quantitative or qualitative neuromuscular block monitoring during non-cardiothoracic surgery

Duration of surgery

Recovery

Participants are monitored in the Post-Anesthesia Care Unit (PACU) for SpO2/FiO2 ratio

Immediate post-surgery period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Qualitative monitoring
• Quantitative monitoring

Trial Overview The study compares two types of monitoring used during surgeries that involve muscle paralysis: quantitative (precise measurement) and qualitative (based on observation). It focuses on the impact these methods have on the patient's oxygen levels and breathing ratio in the post-anesthesia care unit.

How Is the Trial Designed?

Group I: Quantitative monitoring Experimental Treatment 1 Intervention

Group II: Qualitative monitoring Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11776315/

Neuromuscular monitoring and incidence of postoperative ... The aim of this study was to investigate the incidence of postoperative residual neuromuscular blockade (RNMB) in a cohort of patients receiving NMBAs.

2. journals.lww.com journals.lww.com/10.1097/ALN.0000000000004174

Quantitative Neuromuscular Monitoring in Clinical Practice Manually reviewed anesthesia records (n = 2,807) had 2 of 172 (1%) cases with documentation of train-of-four ratios greater than or equal to 0.90 in November ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34813652/

Quantitative Neuromuscular Monitoring and Postoperative ... Quantitative monitoring significantly reduces the risk of residual neuromuscular blockade in the operating room and postanesthesia care unit.

4. blinkdc.com blinkdc.com/blog/why-quantitative-neuromuscular-monitoring-should-be-standard-practice

Why Quantitative Neuromuscular Monitoring Should Be ... Learn how quantitative EMG monitoring outperforms subjective twitch assessments in reducing residual paralysis and improving patient outcomes.

5. xenonhealth.com xenonhealth.com/quantitative-neuromuscular-monitoring-anesthesia/

Quantitative Neuromuscular Monitoring in Anesthesia In sum, quantitative neuromuscular measurements can be used to effectively identify postoperative residual paralysis, thus allowing physicians ...

6. clinicalview.gehealthcare.com clinicalview.gehealthcare.com/article/how-quantitative-neuromuscular-monitoring-advancing-anesthesia-safety

How quantitative neuromuscular monitor is advancing ... Quantitative NMT monitoring enhances anesthesia safety by providing quantifiable data. These continuous, objective measurements of muscle ...