Comparing quantitative and qualitative muscle-relaxant monitoring during non-cardiothoracic surgery

Quantitative Versus qUAlitative NeuromoniToring of neUroMuscular Block for Non-cardiothoracic Surgery (The QUANTUM Trial): Single-center Cluster Randomized Multiple Crossover Trial

This study will test whether using quantitative monitors instead of cheaper qualitative checks lowers oxygenation problems after non-cardiothoracic surgery in adults given rocuronium.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1032 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07084363 on ClinicalTrials.gov

What this trial studies

Adults having non-cardiothoracic surgery under general anesthesia with endotracheal intubation who receive rocuronium will be monitored for neuromuscular block using either quantitative (objective) devices or less expensive qualitative methods. The trial will compare the lowest SpO2/FiO2 ratio in the PACU between the two monitoring approaches. Outcomes will be used to inform an enhanced recovery pathway for surgical patients. The protocol excludes patients intubated before induction, emergency or critically ill ICU admissions, those not paralyzed during surgery, and people with implanted electronic devices, adhesive allergies, or pre-existing neuromuscular disease.

Who should consider this trial

Good fit: Adults (≥18) undergoing non-cardiothoracic surgery with general anesthesia, endotracheal intubation, and rocuronium who do not have pre-existing neuromuscular disease or implanted electronic devices are ideal candidates.

Not a fit: Patients intubated before induction, emergency or critically ill ICU admissions, non-intubated or non-paralyzed cases, those with implanted electronic devices, adhesive allergies, or pre-existing neuromuscular disease are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, quantitative monitoring could reduce postoperative oxygenation problems and help improve recovery protocols after surgery.

How similar studies have performed: Previous studies have suggested quantitative neuromuscular monitoring reduces residual blockade and pulmonary complications compared with qualitative methods, though adoption and definitive outcome data remain variable.

Eligibility criteria

Inclusion criteria:

* Patient age ≥ 18 years old;
* General anesthesia with endotracheal intubation;
* Neuromuscular block with rocuronium.

Exclusion criteria:

* Intubation before induction of anesthesia;
* Critically ill patients admitted from the ICU;
* Emergency cases;
* Non-intubated patients;
* Patients who will not be paralyzed through the surgery (spine).
* Patients with an implanted electronic device (e.g. cardiac pacemaker)
* Patients with allergies to adhesive
* Patients with pre-existing neuromuscular disease (e.g. Myasthenia Gravis)

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Mehmet Turan, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Mehmet Turan, MD

Conditions Neuromuscular Block, Residual