Recruiting

Monitoring Techniques

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07084363

Conditions

Neuromuscular Block, Residual

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quantitative monitoring

Qualitative monitoring

Study Details

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

Study ID

NCT07084363

Start date

Sep 22, 2025

Status verified date

Oct, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Feb 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1032 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Quantitative monitoring

active comparator: Qualitative monitoring

Interventions

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.

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.

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) ]

Central Contacts and Locations

Central contacts

Mehmet Turan, MD

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

Mohammad Khudirat

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Mehmet Turan, MD

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

Mohammad Khudirat

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Oct 10, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-10-10.