Quantitative Versus qUAlitative NeuromoniToring of neUroM... | NCT07084363

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

NCT07084363

Sponsor

The University of Texas Health Science Center, Houston

Status

Recruiting

Last Update Posted

Oct 10, 2025Actual

Enrollment

1,032Estimated

Phase

Not Applicable

Conditions

Neuromuscular Block, Residual

Interventions

Quantitative monitoring
Qualitative monitoring

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2025Actual

Primary Completion Date

Feb 15, 2026Estimated

Completion Date

Apr 1, 2026Estimated

First Submitted Date

Jul 16, 2025

First Submission Date that Met QC Criteria

Jul 16, 2025

First Posted Date

Jul 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2025

Last Update Posted Date

Oct 10, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehmet Turan, Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,032Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quantitative monitoring	Experimental		Device: Quantitative monitoring
Qualitative monitoring	Active Comparator		Other: Qualitative monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mehmet Turan, MD	Contact	(713) 500-6251		Mehmet.A.Turan@uth.tmc.edu
Mohammad Khudirat	Contact	(713) 500-5558		Mohammad.Khudirat@uth.tmc.edu

Overall Officials

Name	Affiliation	Role
Mehmet Turan, MD	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center at Houston	Recruiting	Houston	Texas	77030	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055191	Delayed Emergence from Anesthesia

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.