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

NCT07084363 | Recruiting FDA Device

• 1 other identifier: HSC-MS-25-0337
• Study Type: interventional
• Target: 1,032
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Block, Residual

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Collapsed composite (any vs none) of postoperative pulmonary complications

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

Study Arms (2)

Quantitative monitoring

EXPERIMENTAL

Device: Quantitative monitoring

Qualitative monitoring

ACTIVE COMPARATOR

Other: Qualitative monitoring

Interventions

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.

Quantitative monitoring

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.

Qualitative monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehmet Turan, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Turan, MD

CONTACT

(713) 500-6251; Mehmet.A.Turan@uth.tmc.edu

Mohammad Khudirat

CONTACT

(713) 500-5558; Mohammad.Khudirat@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Designated operating rooms of the hospital will be cluster randomized in this study. For each week of the 24-week trial, the designated operating rooms will be randomized to either quantitative or qualitative TOF monitoring.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: September 22, 2025
• Primary Completion: February 15, 2026
• Study Completion: April 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)