RecruitingNot ApplicableNCT07084363

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

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

1,032 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria8

  • 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)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEQuantitative monitoring

The TetraGraph TOF monitor will be used to quantitatively assess the TOF-ratio. Quantitative monitoring includes objective measurement of the TOF-ratio, as defined by the ratio between the first and the fourth muscular responses and is quantified by acceleromyography. A TOF twitch response ratio equal or greater to 95% (TOF0.95) will be targeted prior to extubation. If TOF0.95 is not reached within 10 min of administering the initial dose of the respective reversal agent, redosing is recommended.

OTHERQualitative monitoring

Clinicians will assess the TOF-ratio. Qualitative monitoring includes subjective assessment of the count and the amplitude of the muscular responses related to neuromuscular block depth. A TOF twitch response count of 4 similarly strong twitches will be targeted prior to extubation. If 4 similarly strong TOF twitch responses are not reached within 10 min of administering the initial dose of the respective reversal agent, redosing is recommended.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07084363


Related Trials