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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07084363
Status
Recruiting
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Conditions

  • Neuromuscular Block, Residual

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 22, 2025
Status verified
Oct 2025
Primary completion
Feb 15, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
1,032 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Quantitative monitoring
  • Active Comparator: Qualitative monitoring

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

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Mehmet Turan, MD
[email protected]
713-500-6251
Mohammad Khudirat
[email protected]
(713) 500-5558

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The University of Texas Health Science Center at Houston· Houston, TX