Quantitative Versus qUAlitative NeuromoniToring of neUroMuscular Block for Non-cardiothoracic Surgery (QUANTUM)

The University of Texas System (UT)

Status: Enrolling

Conditions: Neuromuscular Block, Residual

Treatments: Other: Qualitative monitoring; Device: Quantitative monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07084363

HSC-MS-25-0337

Details and patient eligibility

About

The purpose of this study is to assess the effect of quantitative block monitoring versus less expensive qualitative monitoring treatment effects on the lowest SpO2/FiO2 ratio in the PACU. The results will be incorporated into an enhanced recovery pathway for surgical patients.

Enrollment: 1,032 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,032 participants in 2 patient groups

Quantitative monitoring

Experimental group

Treatment:

Device: Quantitative monitoring

Qualitative monitoring

Active Comparator group

Treatment:

Other: Qualitative monitoring