Neuromuscular Block, ResidualQUANTUMNCT07084363
Quantitative Versus qUAlitative NeuromoniToring of neUroMuscular Block for Non-cardiothoracic Surgery
A study testing Quantitative monitoring and Qualitative monitoring in people with Neuromuscular Block, Residual, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Block, Residual
- What is being tested?
- Quantitative monitoring and Qualitative monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,032 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age ≥ 18 years old;
- General anesthesia with endotracheal intubation;
- Neuromuscular block with rocuronium.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Mehmet Turan, MD, 713-500-6251, Mehmet.A.Turan@uth.tmc.edu
Mohammad Khudirat, (713) 500-5558, Mohammad.Khudirat@uth.tmc.edu
About this study
Official title: 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.
- Conditions
- Neuromuscular Block, Residual
- Being tested
- Quantitative monitoring, Qualitative monitoring
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative monitoringDevice
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 monitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Quantitative monitoring | Experimental | Not described Receives: Device: Quantitative monitoring |
| Qualitative monitoring | Active comparator | Not described Receives: Other: Qualitative monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
lowest SpO2/FiO2 ratio in the PACU (constant for at least 10 minutes)
Measured: During the time in PACU (about 30 minutes to 6 hours)
Secondary outcomes (1)
Collapsed composite (any vs none) of postoperative pulmonary complications
Measured: During length of hospital stay (about 1 day to a week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start22 Sep 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Block, ResidualStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,032 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Turan, The University of Texas Health Science Center, Houston
- Investigators
- Mehmet Turan, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084363
- Sponsor's protocol ID
- HSC-MS-25-0337
- Acronym
- QUANTUM
- Status last verified
- Oct 2025
- First submitted
- 16 Jul 2025
- Last updated
- 10 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Versus qUAlitative NeuromoniToring of neUroMuscular Block for Non-cardiothoracic Surgery (The QUANTUM Trial): Single-center Cluster Randomized Multiple Crossover Trial
- ClinicalTrials.gov ID
- NCT07084363
- Acronym / sponsor ID
- QUANTUM / HSC-MS-25-0337
- Conditions
- Neuromuscular Block, Residual
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,032 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Quantitative monitoring | Experimental | Device: Quantitative monitoring |
| Qualitative monitoring | Active comparator | Other: Qualitative monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age ≥ 18 years old;
- General anesthesia with endotracheal intubation;
- Neuromuscular block with rocuronium.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative monitoringThe 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. | Device | Quantitative monitoring |
| Qualitative monitoringClinicians 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. | Other | Qualitative monitoring |
Primary outcome
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)
1 secondary outcome
Collapsed composite (any vs none) of postoperative pulmonary complications
Time frame: During length of hospital stay (about 1 day to a week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mehmet Turan, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative monitoring and Qualitative monitoring in people with Neuromuscular Block, Residual, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Turan, MD ((713) 500-6251, Mehmet.A.Turan@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.