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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Block, Residual
• Intervention / Treatment: Device: Quantitative monitoring; Other: Qualitative monitoring

• Study Type: Interventional
• Enrollment (Estimated): 1032
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehmet Turan, MD; Phone Number: (713) 500-6251; Email: Mehmet.A.Turan@uth.tmc.edu
• Study Contact Backup: Name: Mohammad Khudirat; Phone Number: (713) 500-5558; Email: Mohammad.Khudirat@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Mohammad Khudirat; Phone Number: (713) 500-5558; Email: Mohammad.Khudirat@uth.tmc.edu
      • Contact: Mehmet Turan, MD; Phone Number: 713-500-6251; Email: Mehmet.A.Turan@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quantitative monitoring	Device: Quantitative 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.
Active Comparator: Qualitative monitoring	Other: Qualitative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
lowest SpO2/FiO2 ratio in the PACU (constant for at least 10 minutes)	During the time in PACU (about 30 minutes to 6 hours)

Secondary Outcome Measures

Outcome Measure	Time Frame
Collapsed composite (any vs none) of postoperative pulmonary complications	During length of hospital stay (about 1 day to a week)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Mehmet Turan, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2025
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: July 16, 2025
• First Submitted That Met QC Criteria: July 16, 2025
• First Posted (Actual): July 24, 2025

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 6, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delayed Emergence from Anesthesia
• Other Study ID Numbers: HSC-MS-25-0337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No