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NCT Number: NCT07084363

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

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.

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Key information

Conditions

Neuromuscular Block, Residual Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Quantitative monitoring

Device

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.

Qualitative monitoring

Other

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.

Primary outcomes

  1. lowest SpO2/FiO2 ratio in the PACU (constant for at least 10 minutes)

    Time frame: During the time in PACU (about 30 minutes to 6 hours)

Secondary outcomes

  1. Collapsed composite (any vs none) of postoperative pulmonary complications

    Time frame: During length of hospital stay (about 1 day to a week)

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Turan, MD

CONTACT

[email protected]

(713) 500-6251

Mohammad Khudirat

CONTACT

[email protected]

(713) 500-5558

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Acronym: QUANTUM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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